(2) Risks however are associated with the use of organs in transplantation. The extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to minimise any risks associated with the transmission of diseases. Well organised national transplant systems and use of the best available medical expertise, technology and innovative medical treatment can significantly reduce the associated risks of transplanted organs in patients such as rejection of the organ.

(16) This Directive should respect the fundamental rights and observe the principles recognised in particular by the Charter of Fundamental Rights of the European Union . In line with that charter and to take account of, as appropriate the Convention on human rights and biomedicine , organ transplantation programmes should be founded on the principles of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient while ensuring anonymity of the deceasedthat strict confidentiality rules and security measures are in place for the protection of the donors' and the recipient(s)s' personal data.

(16a) The competent authority shall consult with the national Data Protection Authority in relation to developing a framework for the transfer of organs' data to and from third countries. The specific regime for the transfer of personal data to third countries as laid down in Articles 25 and 26 of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data1 applies. 1 OJ L 281, 23.11.1995, p. 31.

(19) The competent authorities of the Member States should have a key role to play in ensuring the quality and safety of organs during the entire chain from donation to transplantation and throughout the patient’s recovery based on best medical practice in post-transplantation treatment. As emphasised by the Recommendation of the Committee of Ministers to Member States on the background, functions and responsibilities of a National Transplant Organisation (NTO) of the Council of Europe15, it is preferable to have a single body which is officially recognised and non-profit making with overall responsibility for donation, allocation, traceability and accountability. However, depending especially on the repartition of competences within the Member States, a combination of local, regional, national and/or international bodies may work together to co-ordinate donation, allocation and/or transplantation, provided that the framework in place ensures accountability, co-operation and efficiency

(21) The measures needed to implement this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission. With regard to Article 25, in all cases where implementing measures affecting data protection and security are considered, all relevant stakeholders should be consulted, including the European Data Protection Supervisor.

(22) In particular, power should be conferred on the Commission to lay downorder to achieve the objectives of this Directive, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union concerning, where the organs concerned are to be exchanged between Member States, the procedures for the transmission to transplantation centres of the information on the characteristics of the organs, the procedures needed to ensure the traceability of the organs, including labelling requirements, and the procedures for the reporting of serious adverse events or reactions. Since these measures are of general scope and are designed to amend non-essential elements of this Directive, or to supplement this Directive with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(a) ‘authorisation‘ means authorisation, accreditation, designation or licensing, depending of the concepts used in each Member State;, or registration with a public body for the provision of health care provided that the functions of that public body include ensuring that the registered body complies with the rules laid down in this Directive.

(aa) "competent authority/organisation/institution" means one or more non-profit authority(ies), organisation(s) and/or institution(s), whether public or private, responsible for implementing the requirements of this Directive;

(j) “procurement organisation” means a health care establishment, a team or a unit of a hospital or another body which is authorised by the competent authority/organisation/institution to undertake procurement of human organs

(c) establish the qualifications required by the health care personnel involved at all stages of the chain from donation to transplantation or disposal, and develop specific training programmes for personnel in accordance with recognised international standards.

1. Member States shall ensure that medical activities in procurement organisations, such as donor selection and evaluation, are performed under the advice and the supervision of a medical doctor as defined in Directive 2005/36/EC.

(a) the organisations, bodies or companies involved in the transportation of organs have appropriate standard operating procedures in place to ensure the integrity of the organ during transport and that transport time is optimised and where possible minimised.

2. Member States shall ensure the implementation of a donor identification system that can identify each donation and each of the organs associated with it. Member States shall ensure that this donore implementation of a donor and recipient identification system that are designed and selected in accordance with the aim of collecting, processing or using no personal data or as little personal data as possible. I, making in particular, use is to be made of the possibilities for pseudonymisation or rendering individuals anonymousof pseudonymisation methods, as well as that the necessary technical and organisational measures are in place for the security of those data.

3a. Member States shall, in accordance with Article 24, lay down rules on penalties applicable to: (a) the unauthorised accessing of data or systems permitting the identification of donors or recipients; (b) any use which is made of systems or data permitting the identification of donors or recipients with a view to tracing donors or recipients other than for necessary medical purposes.

1. Member States shall ensure that there is a reporting system in place to report, investigate, register and transmit relevant and necessary information concerning serious adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the procurement, testing, preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities.

3a. The Commission, in close cooperation with Member States, the European Parliament and relevant stakeholders, shall examine the possibility of developing a system whereby the wishes expressed by citizens consenting to the donation of organs after they are deceased are taken into account in as many Member States as possible.

3b. Member States shall ensure that systems and registers are in place which are easily accessible for the purposes of recording the wishes of future donors and that the competent authorities give priority to the wishes expressed by a donor over any possible contrary wishes of a spouse, first-degree relative or other person.

Member States shall take all necessary measures to ensure that donors are provided with comprehensive, concrete and unbiased information on organ donation covering the transplantation process, the specific scope, potential use and the risks, including risks of misuse.

1a. Living donations shall be seen as subsidiary to post-mortem donations and only serve as a last resort where no suitable alternative such as an organ from a deceased donor is available. Living donations shall in principle be restricted to donations among close relatives and spouses due to the implicit danger of exploitation.

2a. In order to comply with the principle of non-commercialisation of the human body, Member States shall ensure that a possible compensation to living donors is strictly limited to making good the expenses directly related to the donation such as travelling fees, childminding costs or loss of earnings, avoiding any financial incentives for a potential donor.

2b. The person who has suffered undue damage resulting from an intervention shall be entitled to fair compensation strictly limited to making good the expenses and inconveniences related to the donation.

1a. Member States shall take all necessary measures to ensure that donors and recipients whose data are being processed within the scope of this Directive are only identifiable for persons who can establish a need to know their identities.

Anonymisation of donors and recipients Member States shall take all necessary measures to ensure that all personal data of donors and recipients processed within the scope of this Directive are rendered anonymous so that neither donors nor recipients remain identifiable.rticle 17 deleted

Member States shall designate the competent authority, or authoritie/organisation/institution, or authorities/organisations/institutions (hereafter competent authority/organisation/institution), responsible for implementing the requirements of this Directive.

(e) issue appropriate guidance to health care establishments, professionals and other parties involved in all stages of the chain from donation to transplantation or disposal as well as subsequent treatment and recovery in post-transplantation;

(fa) collect relevant post-transplantation outcome data in order to allow comparable assessment of quality and safety of organ transplantation, which will serve to further improve the transplantation process at the European level.

1. Member States shall ensure that all exchanges of organs from or to third countries, are authorised by the competent authority/organisation/institution. The competent authority shall consult with the national Data Protection Authority for developing a framework for the transfer of data relating to the exchange of organs to and from third countries. The specific regime for the transfer of personal data to third countries as laid down in Articles 25 and 26 of Directive 95/46/EC shall apply.

1. Member States shall report to the Commission before …………....* and every three years thereafter on the activities undertaken in relation to the provisions of this Directive, and on the experience gained in implementing it. 2. Before ……....** and every three years thereafter, the Commission shall transmit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions ,a report on the implementation of this Directive. * 2 years after the entry into force of this Directive. ** 3 years after the entry into force of this Directive.

Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that the penalties are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by […]* and shall notify it without delay of any subsequent amendments affecting them. * 2 years after the entry into force of this Directive.

1. Detailed rules for the following measures shall be adopted in accordance with the procedure referred to in Article 26(3): (a) rules for the updating and transmission of information on human organs characterisation as detailed in the Annex; (b) procedures for ensuring the full traceability of organs, including labelling requirements; (c) procedures for ensuring the reporting of serious adverse events and reactions.deleted

2. DetailedAppropriate rules for the uniform implementation of this Directive, and in particular for the following measures, shall be adopted in accordance with the procedure referred to in Article 26(2):

Article 25a Delegated acts In order to achieve the objectives of this Directive, the Commission shall lay down by means of delegated acts in accordance with Articles 26a, 26b and 26c: (a) rules for the updating and transmission of information on human organs characterisation as detailed in the Annex; (b) procedures for ensuring the full traceability of organs, including labelling requirements; (c) procedures for ensuring the reporting of serious adverse events and reactions.

Article 26a Exercise of the delegation 1. The powers to adopt the delegated acts referred to in Article 25a shall be conferred on the Commission until...*. The Commission shall make a report in respect of the delegated powers at the latest...**, accompanied, where relevant, by a legislative proposal to extend the duration of the delegation of powers. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts shall be conferred on the Commission subject to the conditions laid down in Articles 26b and 26c. * OJ; please insert the date 3 years after the entry into force of this Directive. ** OJ; please insert the date 30 months after the entry into force of this Directive.

Article 26b Revocation of the delegation 1. The delegation of power referred to in Article 25a may be revoked by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission stating the delegated powers which could be subject to revocation. 3. The decision of revocation shall state the reasons for the revocation and shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.

Article 26c Objections to delegated acts 1. The European Parliament and/or the Council may object to the delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by one month. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, the delegated act shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [...]* at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and. * 2 years after the entry into force of this Directive.

(g) "organ" means both a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy; and parts of organs, if it is their function to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation;

1 a. Living donations shall be seen as complementary to post-mortem donations and only serve as a last resort where no suitable alternative, such as an organ from a deceased donor, is available. Living donations shall in principle be restricted to donations among close relatives and spouses due to the implicit danger of exploitation.

2a. In order to comply with the principle of non-commercialisation of the human body, Member States shall ensure that possible compensation for living donors is strictly limited to ensuring healthcare insurance for donation-related long-term medical conditions and to making good the expenses relating to the donation, such as travel expenses, child minding costs, loss of earnings or costs of recovery, and prohibiting any financial incentives for a potential donor.

(2) In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to health-care professionals) and the package leaflet (inserted in the product's packaging when it is dispensed to the patient). On the other hand, as regards the disseminationmaking available of information from the marketing authorisation holder to patients and the general public, the Directive only provides that certain information activities are not covered by the rules on advertising, without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be disseminated.made available. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

(4) Experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to providmake information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

(7) In the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the European Union have become increasingly active as regards healthcare, it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good-quality, objective, reliable and non promotional information on medicinal products by placing emphasis on the interests of patients. They should have the right to easily access certain information such as a summary of product characteristics, and the package leaflet in electronic and printed form.

(8) National competent authorities and health care professionals should remain importantthe main sources of information on medicinal products for the general public. Member States should facilitate the access of citizens to high-quality information through appropriate channels. Marketing authorisation holders may be a valuable source of non promotional information on their medicinal products. This Directive should therefore establish a legal framework for the dissemination of specific information on medicinal products by marketing authorisatWhile there is already a lot of independent information on pharmaceuticals, for example by national authorities or health care professionals, the situation differs very much between Member States and among the different products available. Member States and Commission shoulders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained take much more efforts to facilitate the access of citizens to high-quality information through appropriate channels.

(8a) Without prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public, marketing authorisation holders may be an additional source of non-promotional information on their medicinal products. This Directive should therefore establish a legal framework for the making available of specific information on medicinal products by marketing authorisation holders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained.

(9) In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to the supply of information on prescription-only medicinal products that has been approved by the competent authorities by the marketing authorisation holder, as current Community rules allow the advertising to the general public of medicinal products not subject to prescription, under certain conditions.

(10) Provisions should be established to ensure that only high-quality non- promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated. The information should take into account patients needs and expectations in order to empower patients, allow informed choices and enhance the rational use of medicinal products. Therefore, any information to the general public on prescription-only medicinal products should comply with a set of quality criteriabe approved in advance by the competent authorities und should be supplied only in the approved form.

(11) In order to further ensure that marketing authorisation holders disseminatmake available only high-quality information and to distinguish non-promotional information from advertising, the types of information which may be disseminatedmade available should be defined. It is appropriate to allow marketing authorisation holders to disseminatmake available the contents of the approved summaries of product characteristics and package leaflet, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product-related information. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

(11) In order to further ensure that marketing authorisation holders disseminate only high-quality information andcompetent authority- approved high-quality information in approved form and in order to distinguish non-promotional information from advertising, the types of information which may be disseminated should be defined. It is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflets, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product- related informationcluding the "drug-fact-box".

(12) Information to the general public on prescription-only medicinal products that has been approved by the competent authorities should only be provided through specific channels of communication, including Internet and health-related publications, by the marketing authority holder to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public. Where information is disseminated via television or radioby the marketing authority holder via television, radio or newspapers, magazines and similar publications, patients are not protected against such unsolicited information and such disseminsupply of information should therefore not be allowed.

(12 a) The internet is a major source of information for a growing number of patients. This trend is likely increase in the coming years. In order to adapt to this development and to add to the growing importance of e-health, information on medicinal products should also be made available via independent national health internet websites. These websites should be monitored by competent authorities in the Member States. Member States in co- operation with stakeholders such as health care professionals or patient organisations should be responsible for managing these websites.

(14) Monitoring of information on prescription-only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with Directive 2001/83/EC. Member States should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non-compliance. Monitoring should be based on the control of information prior to its dissemination, unless the substance of thesupply. Only such information thas already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoringt has been approved in advance by the competent authorities should be provided, and it should be provided in the approved form only.

- information by the marketing authorisation holderon medicinal products that has been approved by the competent authorities in the Member States and that has been made available to the general public oin medicinal productapproved form by the marketing authorisation holder and that is subject to medical prescription, which is subject to the provisions of Title VIIIa.

4. The prohibition set out in paragraph 1 shall not apply to vaccination campaigns and other campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the Member States.

Directive 2001/83/ECArticle 100 - a (new), to be inserted before Article 100a

Article 100 -a Member States and the European Commission shall support independent information on medical products to the general public. To this end the Member States shall present a national program on information to patients following consultation with stakeholders such as health care professionals and patient organisations. Information shall be presented in electronic as well as in printed form. The Commission shall provide assistance and organise the exchange of best practice. Member States and the Commission shall grant financial support to independent drug information centres, encourage the development of independent, continuing education programmes for health professionals and the development of their critical appraisal skills.

Directive 2001/83/ECArticle 100 - a a (new), to be inserted before Article 100a

Article 100 –a a Member States shall ensure that the mandatory information referred to in Article 100b (1) shall be made available through national health internet websites in the official language(s) of the Member State where the website is registered. Such websites shall be monitored by a competent authority of the Member State or by a body assigned by the competent authority in accordance with Article 100g.The websites shall be administered and managed in co-operation with stakeholders such as health care professionals and patient organisations. The information shall communicate both benefits and risks in a clear descriptive manner that is patient friendly and link to the national medicinal products safety website.The internet websites shall provide patients with the mandatory information on all available medicinal products in that Member State both centrally approved by the European Medicines Agency and locally approved in that Member State. The internet websites should also include general information about medicinal and non-medicinal treatment of various diseases, including rare diseases, in order to promote a high level of public health. They may also contain other information as referred to in Article 100b (2) and as defined by the Commission’s guidelines concerning information allowed.

1. Member States shall allow the marketing authorisation holder to disseminatmake available, either directly or indirectly through a third party, information that is acting in the name of the marketing authorization holder, information that has been approved by the competent authorities to the general public or members thereof on authorised medicinal products subject to medical prescription provided that ithis information and the way it is supplied is in accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIII. When such information is made available, the marketing authorisation holder and any third party shall be identified, and any third party that acts on behalf of the marketing authorisation holder shall be clearly identified as such.

The following types of information onmarketing authorisation holder shall, in respect of authorised medicinal products subject to medical prescription may be disseminated by the, marketing authorisation holder available to the general public or members thereof: a) the summary of product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities, and the publicly accessible version of the assessment report drawn up by the competent authorities;. A drug-fact-box shall be added to the package leaflet. The information provided in the drug-fact-box shall be presented in a form that is clearly legible, prominent and clearly distinguishable from the rest of the text. This drug-fact-box shall contain a short description of the necessary facts of the medicinal product in order to enable the patient to understand the utility and the possible risks of the medicinal product and in order to apply the medicinal product safely and in the right way. It shall also contain a short summary of the results of the clinical trials. Before supplying it, the drug-fact-box shall be approved by the competent authorities; and prior to such approval, patient organizations shall be heard in an appropriate way in order to guarantee a form that is suitable to the patients. This information shall be made available both in electronic and printed form in all languages of the EU and in a format accessible to people with disabilities.

b) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different way;

d) medicinal product-related information about non-interventional scientific studies, or accompanying measures to prevention and medical treatment, or. Such information which presents the medicinal product in the context of the condition to be prevented or treatedshall be vetted by the Agency prior to its being made available in accordance with Article 20 b (1) of Regulation EC (No) 726/2004.

Information on authorised medicinal products subject to medical prescription disseminatedthat has been approved by the competent authorities and is made available by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio. It, radio or newspapers, magazines and similar publications. The marketing authorisation holder shall be allowed to supply the information approved in Article 100b on the internet. This information shall not be supplied to the general public or members thereof unasked or actively and shall only be made available through the following channels:

1a. Within one year of the entry into force of this Directive, the Commission shall, following a public consultation with patient and consumer organisations, doctor and pharmacist organisations, Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability and the accuracy of the summaries of product characteristics and the packaging leaflets and their value to the general public and healthcare professionals. Following an analysis of the above data, the Commission shall, if appropriate, put forward guideline proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.

1. Member States shall ensure that there are adequate and effective methods of monitoring to avoid misuse when information on authorised medicinal products subject to medical prescription is disseminated by the marketing authorisation holder to the general public or members thereofmisuse is avoided by securing that only the marketing authorisation holder supplies information, and only such information which has been approved by the competent authorities about approved medicines subject to medical prescription, and in the form which has been approved for the dissemination to the general public or members thereof. By way of derogation Member States may continue those types of control mechanism which they have been implemented before 31.12.2008. The Commission verifies and approves these systems.

1. Member States shall ensure that marketing authorisation holders register Internet websites containing authority- approved information on medicinal products with the national competent authorities of the Member State of the country code Top Level Domain used by the website concerned, prior to making it available to the general public. Where the website does not use a country code Top Level Domain, the marketing authorisation holder shall select the Member State of registration.

Internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites without their explicit prior consent or the appearance therein of unsolicited material actively distributed to the general public or members thereof. Those websites shall not contain web-TVInternet websites may provide video content if it is useful for the safe and effective use of the medicine. Video contents shall only reflect the package leaflet, the summary of the characteristics and the drug-fact-box and hints how to use this medicine safe and effectively. Before publication video contents must be approved by the competent authorities.

2a. The registered internet websites shall display a notification at the top of each website page informing the public that the information contained therein is developed by a named marketing authorization holder. A link to the EudraPharm database on medicinal products shall also be included in that notification.

(a) If a Member State has reasons for doubts as to whether the translation of the reproduced information is correct, it may require a marketing authorisation holder to provide for a certified translation of the authority-approved information disseminated on the Internet website registered with the national competent authority of another Member State.

(b) If a Member State has reasons for doubts as to whether the authority- approved information disseminated on an Internet website registered with the national competent authorities of another Member State complies with the requirements of this Title, it shall inform that Member State of the reasons for its doubts. The Member States concerned shall use their best endeavours to reach agreement on the action to be taken. If they fail to reach an agreement within two months, the case shall be referred to the Pharmaceutical Committee set up by Decision 75/320/EEC. Any necessary measures may only be adopted after an opinion has been delivered by that Committee. Member States shall take account of opinions delivered by the Pharmaceutical Committee and shall inform the Committee of how its opinion has been taken into account.

5. Member States shall allow marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this Directive. The statement shall identify the national competent authority monitoring the website concerned. It shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval.

a) keep available for the competent authorities or bodies responsible for monitoring information on medicinal products that have approved the information in advance, a sample of all information disseminatedmade available in accordance with this Title and information on its volume of disseminatprovision, together with a statement indicating the persons to whom it is addressed, the method of disseminatprovision and the date of first disseminatprovision,

By [insert specific date five years from the entry into force of amending directive] at the latest, the Commission shall publish a report on the experience acquired in the implementation of this Title after consulting the patient organisations and the members of health care professions and shall also assess the need for a review thereof. The Commission shall submit this report to the European Parliament and to the Council.

H. whereas it is recognised that, ideally, the best way of fighting against organ trafficking and trafficking in personthe trafficking of organs and of human beings for the purpose of the removal ofing organs is to increase the number of available organconstitutes a severe violation of human rights,

Ha. whereas there is a strong link between illegal organ trafficking and the trafficking of persons for the purpose of removing organs and the legal system of organ donation because, on the one hand, the non-availability of organs in the legal system acts as an incentive for illegal activities, and, on the other, illegal activities severly undermine the credibility of the legal system of organ donation,

J. whereas living donation rates also differ substantially between Member States, and it seems that not all Member States realise their potential for living donationcan be a helpful additional measure for patients who cannot get the organ they need via post- mortem transplantation, but emphasising that living donation can only be considered if any illegal activity and payment for the donation has been ruled out,

1. Welcomes the proposal to establish a European Action Plan on Organ Donation and Transplantation for the period 2009- 2015(2009-2015) adopted by the European Commission in December 2008, which sets out a cooperative approach between Member States through a set of priority actions, based on the identification and development of common objectives and the evaluation of donation and transplantation activities through agreed indicators that might help to identify benchmarks and best practices;

2. Looks forward to the Commission´s above-mentioned proposal for a directive, which should set quality and safety requirements for the donation, procurement, testing, preservation, transportation and distribution of organs across the EU; stresses, nonetheless, that the forthcoming legislative framework should not create an excessive administrative burden for Member States; points out that the new legislative document should complement and reinforce efforts made by Member States to achieve an active and efficient method of coordination without preventing the introduction or maintenance of more stringent measures;deleted

4. Considers that to ensure that organs available for therapy are not wasted, it is important that there are no legal barriers tois a clearly defined legal framework regarding their use and that society trusts the donation and transplantation system;

7a. Welcomes the activities of Eurotransplant and Scanditransplant, but notes that exchanges of organs outside these systems and between these systems can be significantly improved, especially for the benefit of patients in small countries;

96a. Emphasises that the identification of potential donors has been considered one of the key steps in the process of deceased donation; stresses that the appointment of a key donation person at hospital level (transplant donor coordinator), whose main responsibility is to develop a proactive donor detection programme and optimize the entire process of organ donation, is the most important step towards improving donor detection and organ donation rates;

12. Endorses measures which aim at protecting living donors and ensuring that organ donation is made altruistically and voluntarily, without any payment other than compensation which is strictly limited to covermaking good the expenses and inconvenience relating to donationincurred in donating an organ, such as travel expenses, childminding costs, loss of earnings or recovery costs, prohibiting any financial incentives or disadvantages for a potential donor; urges Member States to define the conditions under which compensation may be granted;

17. Calls on Member States to reach the full potential of deceased donation by establishing efficient systems for identifying organ donors and by promoting transplant donor coordinators in hospitals across Europe; asks Member States to evaluate the use of organs from "expanded" criteria donors, taking into account (i.e. older donors or those who have certain diseases), taking into account donor and recipient protection and the quality and safety aspects;

18. Calls on Member States to explore the promotion of donation from living donors as a complement to deceasedEmphasises that living donation should be seen as subsidiary to post- mortem donations and should only serve as a last resort where no suitable alternative, such as organs from a deceased donor, is available; advises the Member States to allow living donation only among close relatives and between spouses owing to the implicit danger of exploitation; insists that Member States that extend living donation to other groups must have strict regulations in place to prevent any kind of pressure being exerted or payment being made for the donations;.

18a. Stresses that living donors should be treated in accordance with the highest medical standards and without any financial burden for themselves when a medical problem occurs which is caused by the transplantation process, and any loss of earning as consequence of the transplantation or any medical problem should be avoided. The donors should be protected against discrimination in the social system.

23. Points out that there is a link between organ shortage and organ trafficking and trafficking in persons for the purpose of the removal of organs; eEmphasises that any commercial exploitation of organs that denies an equitable access to transplantation is unethical, is inconsistent with the most basic human values, contravenes Article 21 of the Convention on Human Rights and Biomedicine and is prohibited under Article 3(2) of the EU Charter on Fundamental Rights; stresses that increasing organ availability in the Member States will contribute to a better control of these practices by avoiding citizens of the Union having to search for an organ outside the EU and national legislative and ethical frameworks;

23a. Points out that the organ shortage and organ trafficking and trafficking in persons for the purpose of the removal of organs are linked in two ways: firstly, increased organ availability in the Member States would contribute to better monitoring of these practices, by obviating any need for EU citizens to consider seeking an organ outside the EU, and, secondly, illegal activity seriously undermines the credibility of the legal organ donation system:

23b. Repeats the recommendations on the fight against the organ trade made in the Adamou-report on organ donation and transplantation1 and takes the view that these should be taken fully into account by the Commission when drafting the action plan; insists that awareness of the problem within the Commission and Europol needs to be increased; 1 European Parliament resolution of 22 April 2008 on organ donation and transplantation: Policy actions at EU level (2007/2210 (INI))

23c. Emphasises the importance of the World Health Assembly to be held in May 2010 and urges the Commission and the Council to fight strongly at WHO level for the principle of voluntary and unpaid donation;

23e. Notes the report by David Matas and David Kilgour entitled 'Bloody Harvest. The killing of the Falun Gong for their organs', and asks the Commission to present a report on the allegations made in the book to the European Parliament and the Council;

24a. Strongly rejects the behaviour of some health insurance organisations in encouraging patients to participate in transplant tourism and asks the Member States to monitor strictly and punish such behaviour;

24b. Emphasises that patients who have received an organ under illegal circumstances cannot be excluded from healthcare in the European Union; points out that as in any other case a distinction should be drawn between the punishment for illegal activity and the need for treatment;

1a. Calls on the Commission to assure full application of the Charter of Fundamental rights in all aspects of the Union's external action and the consistency between Union's external action and its other policies wherein the human rights shall be mainstreamed;

3. Considers, in this context, that in future legislation Parliament should insist on an arrangement whereby trade advantages, including those stemming from free trade agreements, can be suspended temporarily by the Commission alone if sufficient evidence of human rights or labour rights violations is found, either on its own initiative oror shall be suspended by the Commission at the request of a certain number of Member States and/or the European Parliament;

5. Calls on the Commission to table a proposal for a regulation banning the import into the EU of goods produced using slave, child or forced labour in violation of basic human rights standards; emphasises that such a regulation would have to enable the EU to investigate specific claims;

6b. Calls on the Commission to review the EU export regulations in the field of sale, supply, transfer or export of arms and related materiel of all types, including ammunition, equipment and spare parts, to the countries or to regimes that are likely to use them for internal repression of the civil society and violations of human rights;

A. whereas, according to Article 174 of the Treaty on the Functioning of the European Union, in order to promote its overall harmonious development, the Union shall develop and pursue its actions leading to the strengthening of its economic, social and territorial cohesion, and in particular, the Union shall aim at reducing disparities between the levels of development of the various regions and the backwardness of the least favoured regions such as rural areas, areas affected by industrial transition, and regions which suffer from severe and permanent natural or demographic handicap,

B. whereas the strategic dimension of cohesion policy guaranteeing consistency with the European Union priorities - making Europe and its regions more attractive places in which to invest and work, improving knowledge and innovation for growth and creating more and better jobs - is provided and highlighted through Council Regulation (EC) No 1083/2006 (hereinafter: General Regulation), the Community strategic guidelines on cohesion (hereinafter: Strategic Guidelines), the National Strategic Reference Framework (NSRF) and the Operational Programmes (OP),

5. NReiterates its appreciation of the national efforts resulting in average allocation of expenditure for the achievement of the Lisbon agenda of 65% of the available funds in the convergence regions and 82% in the regional competitiveness and employment regions, exceeding the levels originally requested; notes with satisfaction that a total of EUR 63 billion is reported as allocated to Lisbon earmarking projects and that project selection under Lisbon earmarking is at the same level or slightly faster than selection for other actions;

6. Notes that the progress rate among CSG themes is highest in the Territorial Dimension theme (30%), above average for ‘Improving knowledge and innovation for growth’, but below 27.1% in the case of the other two guidelines and that, moreover, selection rates are above average for Lisbon earmarked projects in both Convergence and Regional Competitiveness and Employment objectives, but amount only to 20.5% in the European Territorial Cooperation objective; regrets that, in the absence of output and result indicators for all Member States, the analysis of policy performance as presented in the strategic report has proved to have serious limitations; calls on the Commission, therefore, to review its administrative reporting requirements and calls on the Member States to be more disciplined about providing data on programme implementation;

7a. Believes that corrective measures need to be promptly taken to improve poor performance in some priority areas; calls on Member States in this context to step up efforts to improve project selection in the delayed themes, and to accelerate implementation of all selected projects so as to avoid the risk of not reaching the agreed objectives;

7b. Considers that rapid project selection and implementation is particularly needed for the activities aimed at improving human capital, supporting labour markets and enhancing social inclusion in order to overcome the negative impacts of the economic crisis;

7c. Highlights the fact that several Member States confirmed that the discipline imposed by the earmarking exercise has improved the quality and focus of programming; moreover Member States unanimously considered that maintaining fundamental priorities of their National Strategic Reference Frameworks and Operational Programmes linked to the Lisbon Strategy is the best instrument to tackle the crisis, and reconfirmed the relevance of the medium and long term objectives set out in these documents;

8. Underlines the fact that effective selection and implementation of projects in some areas is hampered by missing relevant preconditions, such as the lack of clear national priorities for certain areas of intervention, belated transposition of EU laws and lack of institutional and administrative capacity; calls therefore on Member States and regions to facilitate policy implementation by tackling these challenges and in particular by improving the legal framework in the field of state aid, public procurement and environmental rules and pursue institutional reforms;

13a. Considers that the signs of recovery from the crisis are fragile, and in the coming years Europe has to tackle its structural weaknesses, also through Cohesion Policy interventions; stresses therefore the need for a thorough analysis of the impact of measures aimed at counteracting the crisis;

15. Highlights the particular added value of more synergies between ERDF and ESF, since experience clearly proves that successful performance of ESF-financed programmes is essential in order to maximise the effectiveness of ERDF funding for economic actions; notes also that greater coordination would be welcome between cohesion policy instruments and rural development policy instruments, since achieving more synergies between ERDF and EAFRD is similarly important;

18a. Considers that strategic reporting, as a valuable tool of monitoring the progress of implementation creates a basis for peer review and strategic debate on EU level, therefore encourages Member States to adopt more analytical and strategic approach while elaborating national reports, and expects stronger focus on outputs, outcomes, as well as reasons for the failure to achieve the targets;

(23) The activities developed under Horizon 2020 should aim at promoting equality between men and women in research and innovation, by addressing in particular thHorizon 2020 funded research activities should comply with the EU acquis communautaire with regard to equal opportunities between men and women. Horizon 2020 should pay attention to excellent science uanderlying causes of gender imbalance, by exploiting the full potential of both female and male to professional qualification of scientific and research personal of both sex involved in researchers, and by integrating the gender dimension into the content of projects in order to improve the quality of research and stimulate innovation. Activities should also aim at the implementation of the principles relating to the equality between women and men as laid down in Articles 2 and 3innovation. In order to assure the effective use of EU funding, the principal distinction for EU research funding should be the excellence of science project and the professional qualification of the Treaty on European Union and Article 8 TFEUsearch staff.

(24) Research and innovation activities supported by Horizon 2020 should respect fundamental ethical principles. The opinions of the European Group on Ethics in Science and New Technologies should be taken into account. Research activities should also take into account Article 13 TFEU and reduce the use of animals in research and testing, with a view ultimately to replacing animal use. Horizon 2020 funding of research activities must respect the legislative provisions and customs of the Member States. All activities should be carried out ensuring a high level of human health protection in accordance with Article 168 TFEU. (EU Framework Programs must respect the national constitutional law of Member States when establishing funding for research. EU cannot fund research which is not authorized in Member States.)

(25) The European Commission does not explicitly solicit the use of human embryonic stem cells. The use of human stem cells, be they adult or embryonic, if any, depends on the judgement of the scientists in view of the objectives they want to achievAttention should be paid to the considerable differences between national legislations of Member States with regard to research using human embryos and human embryonic stem cells. EU research policy should not lead to harmonize national legislation of Member States. The Commission should remind its declaration, with regard to the 7th FRP, to continue the current practice and isnot subjecmit to stringent Ethics Review. No project involving the use of human embryonicthe Regulatory Committee proposals for projects which include research activities which destroy human embryos, including for the procurement of stemll cells should be funded that does not obtain the necessary approvals from the Member States. No activity should be funded that is forbidden in all Member States. No activity should be funded in a Member State where such activity is forbidden1. This commitment should be included in this Regulation in order to ensure legal continuity. __________________ 1 Point 12 of the Commission statement regarding Article 6 annexed to Decision 1982/2006/EC of the European parliament and of the Council of 18 December 2006 concerning the 7th FRP of the EC for research, technological development and demonstration activities, OJ L 412, 30.12.2006, p.1.

1. Linkages and interfaces shall be implemented across and within the priorities of Horizon 2020. Particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies, to bridging from discovery to market application, to cross-disciplinary research and innovation, to social and economic sciences and humanities, to fostering the functioning and achievement of the ERA, to the development of research into European legal systems, to cooperation with third countries, to ethical responsible research and innovation including gender, andthe respect of equal opportunities between men and women in research, to enhancing the attractiveness of the research profession for both sexes and to facilitating cross-border and cross-sector mobility of researchers.

Horizon 2020 shall ensure the effective promotion of gender equality and the gender dimensiomust respect scientific excellence and professional qualification of research professionals when promoting equal opportunities for men and women in research and innovation content.

4. Research on other types of human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member States involved. No funding shall be granted for research activities that are prohibited in all the Member States. No activity shall be funded in a Member State where such activity is forbidden.

(24) Research and innovation activities supported by Horizon 2020 should respect human rights and fundamental ethical principles. The opinions of the European Group on Ethics in Science and New Technologies should be taken into account. Research activities should also take into account Article 13 TFEU and reduce the use of animals in research and testing, with a view ultimately to replacing animal use. Research activities funded by Horizon 2020 should respect the legal provisions and customs of the Member States. All activities should be carried out ensuring a high level of human health protection in accordance with Article 168 TFEU.

(25) The European Commission does not explicitly solicit the use of human embryonic stem cells. The use of human stem cells, be they adult or embryonic, if any, depends on the judgement of the scientists in view of the objectives they want to achievAttention should be paid to the considerable differences between national legislations of Member States with regard to research using human embryos and human embryonic stem cells. Union research policy should not lead to harmonisation of national legislation of Member States. The Commission should remind its declaration, with regard to the Seventh Framework Programme, to continue the current practice and isnot subjecmit to stringent Ethics Review. No project involving the use of human embryonic stem cells should be funded that does not obtain the necessary approvals from the Member States. No activity should be funded that is forbidden in all Member States. No activity should be funded in a Member State where such activity is forbiddenthe Regulatory Committee proposals for projects which destroy human embryos, including for the procurement of stem cells.1 This commitment should be included in this Regulation in order to ensure legal certainty and continuity. __________________ 1 Point 12 of the Commission statement regarding Article 6 annexed to Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (OJ L 412, 30.12.2006, p. 1).

(25a) Union research policy and research funding should ensure that scientists whose research is funded from the European Union budget, would patent their inventions in the Union. Not patentable research should be excluded from the EU funding in order to ensure responsible use of the European Union budget.

(26) To achieve maximum impact, Horizon 2020 should develop close synergies with other Union programmes in areas such as education, space, environment, competitiveness and SMEs, the internal security, culture and media and with the Cohesion Policy funds and Rural Development Policy, which can specifically help to strengthen national and regional research and innovation capabilities in the context of smart specialisation strategies.; therefore in the Commission's working document of 22 March 2012 on synergies between Horizon 2020 and Cohesion Policy funds, the principles of excellence to which both the research and development as well as regional development policy ought to adhere, are laid down;

1. Linkages and interfaces shall be implemented across and within the priorities of Horizon 2020. Particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies, to bridging from discovery to market application, to cross-disciplinary research and innovation, to social and economic sciences and humanities, to fostering the functioning and achievement of the ERA, to the development of the research into European legal systems, to cooperation with third countries, to ethically responsible research and innovation including gender, and to enhancing the attractiveness of the research profession and to facilitating cross-border and cross- sector mobility of researchers.

4. Research on other types of human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member States involved. No funding shall be granted for research activities that are prohibited in all the Member States. No activity shall be funded in a Member State where such activity is forbidden.

- having regard to its Resolution of 20 May 2010 on the implementation of the synergies of research and innovation earmarked Funds in Regulation (EC) No 1080/2006 concerning the European Fund of Regional Development and the Seventh Framework Programme for Research and Development in cities and regions as well as in the Member States and the Union1, 1 Texts adopted on that date. P7_TA(2010)0189

G. whereas delayed investment in Europe compared with other global powers is essentially due to a lack of private investment and the attractiveness of FP7 for the industrial sector is thus not fully demonstrated; but also, beyond the sums involved, there is a clear need for better coordination between the Union, the Member States, and the Unregions,

16. Welcomes the results of FP7 in favour of SMEs, as regards both the 15% target set in the ‘Cooperation’ chapter and the ‘Eurostars’ programme; is of the opinion that better coordination between FP7 and the Structural Funds could facilitate the participation of under-represented Member States; consequently, calls on the Commission and the national and local authorities to improve the link between the cohesion funds and the Research Framework Programme as these funds should be used to enhance research infrastructure to enable research to reach the level of excellence necessary for access to research funds; in this respect underlines the need to set clear objectives and to assess whether the goals were achieved in these Member States;

16. Welcomes the results of FP7 in favour of SMEs, as regards both the 15% target set in the ‘Cooperation’ chapter and the ‘Eurostars’ programme; is of the opinion that better coordination, coherence and synergy between FP7 and the Structural Funds could facilitate the participation of under-represented Member States;

16a. In this respect, stresses the importance of cohesion policy as this has become a major source of European support in the field of Research & Development and Innovation, as the Member States – in conformity with the second Community Strategic Guideline on cohesion – have devoted a significant amount of their total financial allocations to R&D&I of a knowledge-based economy, resulting in 246 national or regional operational programmes with around EUR 86 billion allocated to R&D&I;

17. Proposes that research and development policies be territorialised; therefore stresses the importance of adapting the research and innovation policies to the specific needs of the territories; notes that since the involvement of regional and local authorities in the design and execution of the research and innovation programmes becomes crucial due to the impossibility of applying the same strategy for development to all the regions;

22a. Stresses the importance of better assistance in the implementation of policies and programmes that enhance the synergies within the research and development value chain (infrastructures - innovation - job creation);

3. Calls on the regions, in line with the ‘smart specialisation’ approach, to develop tailored innovation strategies; stresses that territorial cooperation must be optimised with a view to greater complementarity between regions, calls in this regard for a better articulation and coordination between local, regional, national and European authorities;

3a. Calls for a stronger intergovernmental participation of Joint Programming measures and under Interreg III B, which strengthens the cooperation in research, development and innovation throughout Europe, also with the view to increase participation and better involvement of new Member States in all European research programmes;

5. In the light of the need to improve the extent to which SMEs are benefiting from support for research and innovation, considers that this should be made a focus of cohesion policy, for example in relation to internationalisation or promotion of entrepreneurship, stresses, in this regard, the need for KICs to focus more on SME participation;

6a. Calls on the Commission to strengthen the synergy between different instruments and funds and to develop a multi-fund approach, while respecting the specific conditions set out in the respective legislation;

A. whereas donated tissues and cells, such as skin, bones, tendons, corneas and haematopoietic stem cells, are increasingly used in medical therapies and as starting material for advanced therapy medicinal products (ATMP); whereas the Directive2004/23 asks the Member States to endeavour to ensure voluntary and unpaid donation and endeavour to ensure that the procurement of tissues and cells as such is carried out on a non-profit basis which is a clear legal obligation which can in the case where a Member State does not follow the principal lead to infringement procedure;

Ma. Whereas the donation of some tissues and cells creates a severe risk for the donor, whereas this risk is particular high in egg-cell donation because of the hormone treatment which is necessary to prepare the donation;

Mb. Whereas the Charta of Fundamental Rights which is the leading principle for the European Union and legally binding after entering into force of the Lisbon Treaty prohibits making the human body and its parts as such a source of financial gain.

Mc. Whereas unpaid donation is not only an ethical principle but also necessary to protect the health of the donor and the recipient as the involvement of high amounts of money in the donation process may stimulate the donor to take risks and may hinder the disclosure of risks in his/her medical history.

Md. Whereas there is a lot of evidence that allogenic cordbloood transplantation is already successful for many patients and there are also serious reports that in some cases autologes treatment with this kind of cells can be successful.

1. Welcomes the concluspresentations of the Second Report on Voluntary and Unpaid Donation of Tissues and Cells; which shows that a lot of activities are performed in the Member States to implement the principle of unpaid donation but also shows that still a lot needs to be done

3a. Asks the Commission to carefully monitor the development in the Member States and to examine carefully any reports by actors in the civil society and media under violation of the principle and draw appropriate consequences if necessary infringement procedures.

5. Underlines nonetheless that the principle of altruism is not necessarily violated through the use of non-financial incentives such as benefits-in-kind, which can make donation less burdensome and more attractive, whilst ensuring that the human body shall not be a source of financial gain;deleted

16. Calls on Member States to raise awareness of public and private cord blood banking through information campaigns that may take place, for example, during antenatal classes;prenatal classes but at the same times not exclude the activities of public cordblood banks including appropriately regulated information campaigns by those private cordblood banks.

22. Stresses that in order to guarantee respect for the existing regulatory diversity across Member States whichUnderlines that it is Member States competence to allow, prohibit or regulate research with human embryonic stem cells and in vitro fertilisation but that Member States in this respect need to reflspects differing national values and practices in this field, the s the rules set out in the Directive 2004/23 including the quality and safety and the principal of unpaid donation. Points out that the European Union has limited compe oftence in this areport does not include issues surrounding embryonic stem cell research, therapeutic cloning and in-vitro fertilisation;a and needs to respect when applying this competence the principles of the charter of fundamental rights and the principles applied in the judgement of the European Court of Justice.

23. Calls on the Commission to consider revising the principles governing tissue and cell donation as laid down inpropose as soon as possible a revision of the Directive 2004/23/EC, in order to bring them into line with the principles governing organ donation laid down in Directive 2010/45/EU, and to take into account of scientific developmentsthe new legal situation after the entering into force of the Lisbon Treaty and to take into account the scientific developments, the practical experience of actors in the sector and the recommendations of this report;

23a. Asks the Commission to also propose a revision of Regulation EC 1394/2007 in order to include provision that guarantees the application of the principle of unpaid donation similar to the Directive 2010/45 and to take into account the problems in the implementation of the regulation especially for SMEs.

(1) The ingestion of water is one of the pathways of incorporation of radioactiveharmful substances into the human body. Ingestion of radioactive isotopes or radionuclides can lead to a number of health problems. In accordance with Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation, the contribution to the exposure of the population as a whole, taking into account long-term cumulative exposure, from practices which involve a risk from ionizing radiation must be kept as low as reasonably achievapossible.

(5) The provisions of this Directive adopted under the Euratom Treaty should supersede those of theTreaty on the Functioning of the European Union updates the indicator parameters set out in Part C of Annex I to Directive 98/83/EC, as regardsnd lays down rules on the cmontamination of drinking water byitoring of the presence of radioactive substances in drinking water.

(6) In the event of non-compliance with a parameter that has an indicator function, the Member State concerned should be bound to determine the cause thereof, to assess wthether that non-compliance poses any risk to human health and, where level of the risk to human health including in the long-term and the possibilities for intervention and, on the basis of these findings, take action to ensure the water supply complies with the quality criteria laid down in this directive as soon as possible. This necessary, take remedial action to restore the quality of the watermay go as far as shutting down the facility concerned if the quality of water requires such action. Priority should be given to action which rectifies the problem at source. Consumers should be informed immediately of the risks, the measures already taken by the authorities and the time necessary for the remedial action to take effect.

(7) Consumers should be adequateall be fully and appropriately informed of the quality of water intended for human consumption via easily accessible publications. Updated information regarding areas at risk from potential sources of radioactive contamination, as well as regional water quality, shall be made available to consumers at all times by local administrations.

Without prejudice to the provisions laid down in Article 6(3)a of Directive 96/29/Euratom,1. Member States shall take all measures necessary to establish an appropriate monitoring programme to ensure that water intended for human consumption complies with the parametric values established in accordance with this Directive. A guide of best practices shall be provided to the Member States. 2. Member States shall ensure that the measures taken to implement this Directive will, under no circumstances, have the effect of allowing, either directly or indirectly, any deterioration in the present quality of water intended for human consumption or any increase in the pollution of waters used for the production of drinking water.

Member States shall ensure regular and accurate monitoring of water intended for human consumption in accordance with Annex II in order to check that the concentrations of radioactive substances do not exceed the parametric values laid down in accordance with Article 5. Monitoring shall take account of the long-term cumulative exposure of the population and shall be conducted as part of the checks referred to in Article 7 of Directive 98/83/EC on the quality of drinking water intended for human consumption. It shall include reference analyses aimed at establishing the radioactive content of the water and optimising the analysis strategy and periodic analyses in accordance with the methods set out in Annex III. The monitoring frequency for periodic analyses may be adapted through a risk- based approach, based on the results of reference analyses which shall be mandatory in all cases. In such cases, Member States shall communicate both the grounds for their decision and the results of the reference analyses concerned to the Commission and make them available to the public.

2. Where there is a failure to comply with the parametric values laid defined for radown in accordance with Article 5 occurs, the Member State shall assess whetand for the total indicative dose (TID) from natural sources, the Member State shall immediately assess the level of the risk to human health and the possibilities for intervention, taking into account the local conditions. On the basis of these findings, the Member State shall take action to ensure the water supply complies with the quality criteria laid down in this directive. Where there is a failure poses a risk to human health. In the event that there is such a risk, the Member State shall take remedial action to restore the quality of the wato comply with the parametric values defined for tritium and for the TID originating from human activities, the Member State shall ensure that the investigation which is to be launched immediately establishes the nature, scale and dosimetric impact of the pollution. That investigation shall take into account all the environments liable to be affected and all exposure pathways. The Member State shall ensure that the necessary corrective action is taken to ensure that the water again meets the parametric values. Solutions should be centred on tackling the pollution at source. The necessary remedial action may go as far as shutting down the facility concerned if the water quality requires such action. The Member State shall ensure that the costs of remedial action are borne by the polluter.

3. Where the risk to human health cannot be regarded as trivial, the Member State shall ensure that consumers are notifiedMember States shall ensure that the results of the analyses performed pursuant to Article 8 are published, made publicly available as soon as possible and included in the reports required under Article 13 of Directive 98/83/EC. Where the risk to human health cannot be regarded as trivial, the Member State, together with the responsible actor(s), shall ensure that consumers are alerted immediately and given complete information related to the risk to human health and on how to cope with the problems encountered, which shall be published and made available on the internet as soon as possible. They shall also ensure that alternative uncontaminated water supplies are provided without delay.

(7) To enable the automotive industry to carry out long-term investments and innovation it is desirable to provide indications of how this Regulation should be amended for the period beyond 2020. These indications should be based on an assessment of the necessary rate of reduction in line with the Union's long term climate goals and the implications for the development of cost effective CO2 reducing technology for cars. It is therefore desirable for these aspects to be reviewed, the Commission to make a report and if appropriate proposals made for targets beyond 2020. That report should take into consideration CO2 emissions over the whole life cycle of cars (including manufacture and end-of-life).

(7) To enable the automotive industry to carry out long-term investments and innovation it is desirable to provide indications of how this Regulation should be amended for the period beyond 2020. These indications should be based on an assessment of the necessary rate of reduction in line with the Union's long term climate goals and the implications for the development of cost effective CO2 reducing technology for cars. It is therefore desirable for these aspects to be reviewed, the Commission to make a report and if appropriate proposals made for targets beyond 2020. That report should take into consideration CO2 emissions over the whole life cycle of cars (including manufacture and end-of-life).

(2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation, and approval by an ethics committee prior to commencement.

1. Informed consent shall be written, dated and signed and given freely by the subject or his or her legal representative after having been ducomprehensively and comprehensibly informed of the nature, significance, implications and risks of the clinical trial, and after having received the corresponding information in writing. It shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witness may be given in exceptional cases. The subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given.

(c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is consideredduly taken into account by the investigator;

(ha) the Ethics Committee, with expertise in the relevant disease and the patient population concerned, or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol;

(b) the minor has received all relevant information in a way adapted to his or her age and maturity, from professionalsa medical doctor (either the investigator or member of the trial team) trained or experienced in working with children, regarding the trial, the risks and the benefits;

(c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator in accordance with his or her age and maturity;

(e) the Ethics committee positively assesses that a direct benefit of the clinicial trial for the patient is to be expected, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject.

Article 4 a Ethics Committee 1. Authorisation of a clinical trial shall not be granted before an independent ethics committee has made a positive decision on the clinical trial. The Ethics Committee assessment shall include, in particular, the compliance with the requirements specified in Chapter V, Article 46, Article 47 and Chapter XII. 2. The Ethics Committee shall ensure that the rights, safety and well-being of subjects are protected. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and shall abide by all relevant international norms and standards. The Ethics Committee shall consist of a reasonable number of members, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed trial. 3. Member States shall take the necessary measures to establish Ethics Committees and facilitate their work.

The sponsor shall propose one of the Member States concerned as reporting Member StateMember States concerned shall determine which state shall be the reporting Member State according to an established procedure based on objective criteria which are set by the Commission.

Where the proposed reporting Member State does not wish to be the reporting Member State, it shall agree with another Member State concerned that the latter will be the reporting Member State. If no Member State concerned accepts to be the reporting Member State, the proposed reporting Member State shall be the reporting Member State.deleted

3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 214 days, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.

Where the proposed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within threeseven days following receipt of the comments or of the completed application, the application shall be considered complete, the clinical trial shall be considered as falling within the scope of this Regulation, the clinical trial shall be considered as a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.

(c) within 30 days from the validation date40 days but no earlier than 30 days after receipt of the successfully validated application for any clinical trial with an advanced therapy investigational medicinal product.

5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, it shall state the reasons for this deviation in the assessment report.

Notwithstanding the first and second subparagraphs, in case of other conflict, the Member States involved shall attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision on the conclusion after having heard the Member States involved, and, if appropriate, having taken advice from the European Medicines Agency.

2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons, including a significant number of medical doctors, who collectively have the necessary qualifications and experience.

A substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this Chapter, and if it has been approved by an independent ethics committee before its implementation.

(d) the subject or, where the subject is not able to give informed consent, his or her legal representative has had the opportunity, in a prior interview with a medical doctor who is the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the clinical trial, and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment;

3. Any subject or his legal representative may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent. The withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal.

(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock- management by hospitals, wholesalers and pharmacists and be compatible with other authentication systems already in place in those settings.

6. This Regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide on other category C tests after consultation with stakeholders.

(12a) ‘ device for genetic testing’ means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development.

be addressed by physicians qualified in genetic counselling. The form and extent of this genetic counselling shall be defined according to the implications of the results of the test and their significance for the person or the members of his or her family, including possible implications concerning procreation choices. 5. Consent. A device may only be used for the purpose of a genetic test after the person concerned has given free and informed consent to it. The consent has to be given explicitly and in writing. It can be revoked at any time in writing or orally. 6. Testing of minors. In case of minors the informed consent of the parents or legal representative shall be obtained; consent must represent the minor’s presumed will and may be revoked at any time, without detriment to the minor. In case of incapacitated adults not able to give informed legal consent, the informed consent of the legal representative shall be obtained; consent must represent the presumed will and may be revoked at any time, without detriment to the person. Devices predicting a genetic condition that has implications for diseases in adulthood or for family planning shall not be used in minors unless preventive means are available before reaching the age when the person tested is able to give consent. 7. A device may only be used for the determination of sex in connection with prenatal diagnosis, if the determination fulfils a medical purpose and if there is a risk of serious gender specific hereditary diseases. By way of derogation of Article 2(1) and (2) this also applies to products which are not intended to fulfil a specific medical purpose. 8. The provisions of this Article on the useArticle 4a 1. A device may only be used for the purpose of a genetic test if the indication is given by persons admitted to the medical profession under the applicable national legislation after a personal consultation. 2. A device may be used for purposes of a genetic test only in a way that the rights, safety and well-being of the subjects are protected and that the clinical data generated in the course of the genetic testing are going to be reliable and robust. 3. Information. Before using a device for the purpose of a genetic test the person mentioned in paragraph 1 shall provide the person concerned with appropriate information on the nature, the significance and the implications of the genetic test. 4. Genetic counselling. Appropriate genetic counselling is mandatory before using a device for the purpose of predictive and prenatal testing and after a genetic condition has been diagnosed. It shall include medical, ethical, social, psychological and legal aspects and has to of devices for the purpose of genetic tests do not prevent the Member States from maintaining or introducing for reasons of health protection or public order more stringent national legislation in this field.

4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that, within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.

(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices;

In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safeas specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX. Laboratory tests performed by a reference laboratory shall focus on in particular analytic sensitivity and sperformance that is at least equivalent, as specified in Section 5.4 of Annex VIII ancificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established in Sfection 3.5 of Annex IX.

In case of more than one Member State concerned, where there is a disagreement on whether the clinical performance study should be approved, the member states concerned shall make an attempt to agree on a conclusion. If no conclusion is found, the European Commission takes a decision after hearing the member states concerned, and if appropriate taking advice from EMA.

The Member States shall take all appropriate measures to encourage healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.

– having regard to the Preamble and to Articles 2, 12, and 24 of the Convention on the Rights of the Child, adopted in 1989, which refer to non-discrimination, the right of the child to be heard, and the protection of maternal, infant and child health, in addition to developing family planning education and services,

- having regard to the Declaration of the Right of the Child1 which states that the child, by reason of his physical and mental immaturity, needs special safeguards and care, including appropriate legal protection, before as well as after birth, __________________ 1 Adopted by UN General Assembly Resolution 1386 (XIV) of 10 December 1959

- having regard to the US House of Representatives Congressional Record Extension of Remarks entitled "Documents reveal deceptive practices by abortion lobby" on 8 December 2003, demonstrating how abortion promotion groups are planning to push abortion not by direct argument but by twisting words and definitions and bypassing national laws;

- having regard to Parliamentary Assembly of the Council of Europe (PACE) motion for resolution of 11 May 2010 on 'Sex-selective abortion – 'Gendercide'', inviting its Member States to 'condemn sex-selective abortion, wherever and whenever it occurs',

- having regard to Art. 168 (7) of the Treaty of the Functioning of the European Union stating that Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care;

- having regard to ECJ ruling C-34/10 stating that as a matter of scientific fact a new human life begins at conception, and that the human embryo constitutes a precise stage in the development of the human body;

– having regard to its resolutions of 29 September 19944 on the outcome of the Cairo International Conference on Population and Development, and 4 July 19965on the follow-up to that Conference, and the numerous reservations expressed by States especially on the issue of SRHR and abortion,

A. whereas sexual and reproductive rights are human rights, the violations of which constitute breaches of women's and girls' rights to equalitywomen and girls are entitled to enjoy equal opportunities, non-discrimination based on sex, dignity and health, and freedom from inhuman and degrading treatment;

A b. whereas the Preamble of the Universal Declaration of Human Rights states: "Whereas recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the world," and UDHR Article 3 states, "Everyone has the right to life, liberty and security of person.";

A c. whereas the International Covenant on Civil and Political Rights (ICCPR) implicitly recognizes the human rights of unborn children by providing in Article 6 that capital punishment "shall not be carried out on pregnant women.";

B a. whereas no international legally binding treaties or conventions define the term "sexual and reproductive health and rights" ; whereas the WHO dictionary demonstrates the "inclusive language" approach: "sexual and reproductive health" includes "methods of fertility regulation" which includes "termination of pregnancies (abortion)"

K a. whereas UN Treaty monitoring bodies have no competency to interpret these treaties in ways that create new State obligations or that alter the substance of the treaties; accordingly, any UN treaty monitoring body that interprets a treaty to include a right to abortion acts beyond its authority and contrary to its mandate ; whereas such ultra vires acts do not create any legal obligations for states parties to the treaty, nor should states accept them as contributing to the formation of new customary international law;

1. Recalls that ‘health is a fundamental human right indispensable for the exercise of other human rights’ and that the EU cannot reach the highest attainable standard of health unless the SRHR of all are fully acknowledged and promoted;

1 a. Recalls that the special committee set up by the United Nations General Assembly when preparing for the Convention on the Rights of Persons with Disabilities regularly stressed that the term sexual and reproductive health did not create any new human right or any new international obligation for the States, and did not change the content of the right to healthcare as found in Article 12 of the International Covenant on Economic, Social and Cultural Rights and the United Nations Convention on the Rights of the Child: ''The Ad Hoc Committee notes that the use of the phrase 'sexual and reproductive health services' would not constitute recognition of any new international law obligations or human rights. The Ad Hoc Committee understands draft paragraph (a) [related to the health services, including sexual and reproductive services, to be rendered to the disabled persons] to be a non- discrimination provision that does not add to, or alter, the right to health as contained in Article 12 of the International Covenant on Economic, Social and Cultural Rights or Article 24 of the Convention on the Rights of the Child. Rather, the effect of paragraph (a) would be to require States Parties to ensure that where health services are provided, they are provided without discrimination on the basis of disability.'' 1 __________________ 1 Ad Hoc Committee on a Comprehensive and Integral International Convention on the Protection and Promotion of the Rights and Dignity of Persons with Disabilities, Report of the 7th session (New York, 16 January - 3 February 2006), Note 4, http://www.un.org/esa/socdev/enable/right s/ahc7re¬port-e.htm:

4. Notes that even though it is a competence of Member States to formulate and implement policies on SRHR, the EU can exercise policy-making competence in the area of public health and of non- discrimination, and support better implementation of sexual and reproductive rights;

4 a. Asserts that, when implementing the specific clauses on the prohibition on coercion or compulsion in sexual and reproductive health matters agreed on at the Cairo International Conference on Population and Development, as well as the legally binding international human rights instruments, the EU acquis communautaire and the Union policy competencies in these matters, Union assistance should not be provided to any authority, organisation or programme which promotes, supports or participates in the management of any action which involves such human rights abuses as coercive abortion, forced sterilisation of women and men, determining foetal sex resulting in prenatal sex selection or infanticide;

6 a. recalls that there exists no "human right to abortion" under international law, either by way of treaty obligation or under customary international law, and recalls that no international legally binding United Nations treaty can accurately be cited as establishing or recognizing a right to abortion;

upholds the universal human right to conscientious objection together with the responsibility of the State to ensure that patients are able to access lawful medical care in a timely manner in particular in cases of emergency prenatal and maternal health care, and recalls that no person, hospital or institution shall be coerced, held liable or discriminated against in any manner because of a refusal to perform, accommodate, assist or submit to an abortion or any act which could cause the death of a human foetus or embryo, for any reason;

9. Underlines that in no case must abortion be promoted as a family planning method and recalls that following internationally legally binding obligations every child regardless of sex has the right to appropriate legal protection before as well after birth;

11. Underlines that even when legal, abortion is often prevented or delayed by obstacles to the access of appropriate services, such as the widespread use of conscientious objection, medically unnecessary waiting periods or biased counselling; stresses that Member States should regulate and monitor the use of conscientious objection so as to ensure that reproductive health care is guaranteed as an individual's right, while access to lawful services is ensured and appropriate and affordable referrals systems are in place;deleted

15. Calls on Member States to ensure compulsory,propose age-appropriate and gender- sensitive sexuality and relationship education for all children and adolescents (both in and out of school)sex-specific sexuality, affective and relationship education for adolescents; recalls - with regard to the principle of "Public Policy Doctrine" and internationally accepted standards - that parents or legal guardians of a child have the liberty to ensure that their children receive an education in conformity with their own convictions, and that the child shall not be compelled to receive teaching on sexuality education including the promotion of SHRH and abortion against the wishes of his or her parents or legal guardians, the best interests of the child being the guiding principle; recalls that the right of parents to educate their children according to their religious or non-religious convictions includes their right to deny any undue interference by state or non-state actors in their education;

16. Stresses that sexuality education mustay include the teaching of natural family planning methods, the fight against stereotypes and prejudices, shed light on gender and sexual orientation discrimination, based on sex and structural barriers to substantive equality, as well as emphasise mutual respect and shared responsibility;

17 a. Urges the Member States to ensure access to non-judgmental information about the post abortion stress syndrome (PASS) as well as immediate and universal access PASS treatments, provided in a safe and non-judgmental manner;

18. Calls on the Commission and the Member States to address the specific SRHRneeds for prenatal and maternal health of people living with HIV/AIDS, with a focus on the needs of women, notably by integrating access to testing and treatment and reversing the underlying socioeconomic factors contributing to the risk to women of HIV/AIDS, such as gender inequality and discrimination;

19. Condemns any violation of the bodily integrity of women, as well as harmful practices intended to control women's sexuality and reproductive self- determination; underlines that these are serious human rights violations that the Member States have a responsibility to urgently address;

21. Reminds the Member States that investments in reproductiveprenatal and maternal health and natural family planning are among the most cost-effective, in terms of development, and the most effective ways to promote the sustainable development of a country;

23. Urges the Commission to ensure that European development cooperation adopts a human rights-based approach and that it has a strong and explicit focus, and concrete targets on SRHRprenatal and maternal health;

23 a. calls on EU delegations in developing countries to work with the governments of those countries to ensure that girl children enjoy their rights without discrimination based on their sex, inter alia by ending the unethical and discriminatory practices of prenatal sex selection, abortion of female foetuses, female infanticide, early forced marriage, female genital mutilation;

23 b. Invites the Commission to maintain in its development priorities the access to quality, affordable, acceptable and accessible prenatal and maternal health care services, relational, affective and sexual education for boys and girls under the prior responsibility of their parents1, voluntary family planning including natural family planning methods, while combating sex based discrimination leading to sex-selective and involuntary abortions, forced sterilization and sexual violence, as well as ensuring the provision of prenatal and maternal health care supplies, including HIV prevention, treatment, care and support without discrimination; __________________ 1 "Parents have a prior right to choose the kind of education that shall be given to their children." Art 26.3 of UNGASS Resolution 217 A (III) of 10 December 1948 (Universal Declaration of Human Rights)

23 d. Further reaffirms the sovereign right of each State to implement the proposals of the present resolution in conformity with its own national laws and with full respect for the various religious and ethical values and cultural backgrounds of its people (Public Policy Doctrine) and in conformity with universally recognized international human rights;

23 e. recalls § 8.25 of the Programme of Action of the International Conference on Population and Development stating: "In no case should abortion be promoted as a method of family planning. (...) Prevention of unwanted pregnancies must always be given the highest priority and every attempt should be made to eliminate the need for abortion. Women who have unwanted pregnancies should have ready access to reliable information and compassionate counselling. Any measures or changes related to abortion within the health system can only be determined at the national or local level according to the national legislative process."

- having regard to the Freedom of Religion or Belief: World Report 2012 conducted by Human Rights without Frontiers International and to the Religious Freedom in the World: Report 2012 conducted by Aid to the Church in Need,

(l) The Guidelines should include the right to conscientious objection to military service as a legitimate exercise of. Firstly, right to conscientious objection should include the right to freedom of thought, conscience and religion, and thefuse military service. EU should call on countries with a system of compulsory military service to allow for an alternative service of a non-combatant or civilian character, in the public interest and not of a punitive nature, and to refrain from punishing, including through prison sentences, conscientious objectors for failure to perform military service. Secondly, as the right of conscientious objection is of much broader scope and cannot be limited to the refusal of a military service, a person should be at liberty to refuse provision of certain services or treatment; or to undergo certain procedures or treatment which are conflicting with his or her beliefs . This right should not be conditioned by providing a certificate of belonging to a particular religious group on the part of a person appealing to the right to conscientious objection as this right belongs to all human beings without distinction.

(3a) In its resolution of 4 February 2014 (2013/2177(INI)) the European Parliament "stresses that the Commission should address more concretely and in detail the issue of carbon leakage, that the 2030 climate and energy policy targets must be technically and economically feasible for EU industries and that best performers should have no direct or indirect additional costs resulting from climate policies". It also "stresses that the provisions for carbon leakage should provide 100% free allocation of technically achievable benchmarks, with no reduction factor for carbon leakage sectors". It is of paramount importance that the Commission reviews the functioning of Directive 2003/87/EC, in this respect.

(3a) The European Council conclusions of 23 and 24 October 2014 on the 2030 Climate and Energy Policy Framework give clear guidance on the continuation of free allocations and carbon leakage provisions after 2020, stating that "the most efficient installations in the sectors at risk of losing international competitiveness should not face undue carbon costs leading to carbon leakage" and that "future allocations will ensure better alignment with changing production levels in different sectors" and "at the same time, incentives for industry to innovate will be fully preserved and administrative complexity will not be increased." The conclusions further underline that both direct and indirect costs for the respective industry sectors will be taken into account as well as the need for affordable energy prices. It is of paramount importance that the Commission reviews the functioning of Directive 2003/87/EC, in that respect.

Article 2a Review of Directive 2003/87/EC Within six months from the entry into force of this Decision (insert number of this Decision when known), the Commission shall review Directive 2003/87/EC, and shall, in accordance with the ordinary legislative procedure submit a proposal to the European Parliament and the Council, in particular with regard to carbon leakage provisions, ensuring that sectors at risk of carbon leakage, at least at the level of best performers, have no direct and indirect additional costs resulting from the Directive.

Article 2a Review of Directive 2003/87/EC By ...+, the Commission shall review Directive 2003/87/EC, taking into account the conclusions of the European Council of 23 and 24 October 2014, in particular with regard to carbon leakage provisions and the continuation of free allocations, better reflecting changing production levels and incentivising the most efficient performance taking into account direct and indirect carbon costs, and if appropriate shall, in accordance with the ordinary legislative procedure, submit a proposal to the European Parliament and the Council. ________________ + OJ: Please, insert the date: six months from the entry into force of this Decision.

(3a) In its resolution of 4 February 2014 (2013/2177(INI)) the European Parliament "stresses that the Commission should address more concretely and in detail the issue of carbon leakage, that the 2030 climate and energy policy targets must be technically and economically feasible for EU industries and that best performers should have no direct or indirect additional costs resulting from climate policies". It also "stresses that the provisions for carbon leakage should provide 100% free allocation of technically achievable benchmarks, with no reduction factor for carbon leakage sectors". It is of paramount importance that the Commission reviews the functioning of Directive 2003/87/EC, in this respect.

(3a) The European Council conclusions of 23 and 24 October 2014 on the 2030 Climate and Energy Policy Framework give clear guidance on the continuation of free allocations and carbon leakage provisions after 2020, stating that "the most efficient installations in the sectors at risk of losing international competitiveness should not face undue carbon costs leading to carbon leakage" and that "future allocations will ensure better alignment with changing production levels in different sectors" and "at the same time, incentives for industry to innovate will be fully preserved and administrative complexity will not be increased." The conclusions further underline that both direct and indirect costs for the respective industry sectors will be taken into account as well as the need for affordable energy prices. It is of paramount importance that the Commission reviews the functioning of Directive 2003/87/EC, in that respect.

Article 2a Review of Directive 2003/87/EC Within six months from the entry into force of this Decision (insert number of this Decision when known), the Commission shall review Directive 2003/87/EC, and shall, in accordance with the ordinary legislative procedure submit a proposal to the European Parliament and the Council, in particular with regard to carbon leakage provisions, ensuring that sectors at risk of carbon leakage, at least at the level of best performers, have no direct and indirect additional costs resulting from the Directive.

Article 2a Review of Directive 2003/87/EC By ...+, the Commission shall review Directive 2003/87/EC, taking into account the conclusions of the European Council of 23 and 24 October 2014, in particular with regard to carbon leakage provisions and the continuation of free allocations, better reflecting changing production levels and incentivising the most efficient performance taking into account direct and indirect carbon costs, and if appropriate shall, in accordance with the ordinary legislative procedure, submit a proposal to the European Parliament and the Council. ________________ + OJ: Please, insert the date: six months from the entry into force of this Decision.

57. Calls on the EU to actively participate in the 59th session of the Commission on the Status of Women, and to continue to fight against all attempts to undermine the UN Beijing Platform for Action concerning, among other elements, access to education and health as basic human rights, and sexual and reproductive rights; abortion shall not be promoted as a form of family planning.

57. Calls on the EU to actively participate in the 59th session of the Commission on the Status of Women, and to continue to fight against all attempts to undermine the UN Beijing Platform for Action concerning, among other elements, access to education and health as basic human rights, and sexual and reproductive rights; abortion shall not be promoted as a sexual and reproductive right.

68. Welcomes the legalisation of same-sex marriage or same-sex civil unions in an increasing number of countries, seventeen at the moment, around the world; encourages the EU institutions and the Member States to further contribute to the recognition of same-sex marriage or same-sex civil union as a political, social and human and civil rights issue;deleted

69. Welcomes the annulment in October 2013 of the Moldovan law prohibiting the ‘propagation of any other relations than those related to marriage or family’, and calls on Lithuania and Russia to follow the Moldovan example; regrets the outcome of the Croatian referendum of December 2013, which endorsed a constitutional ban on equal marriage; stresses that such referendums contribute to a climate of homophobia and discrimination; considers that LGBTI persons’ fundamental rights are more likely to be safeguarded if they have access to legal institutions such as cohabitation, registered partnership or marriage;deleted

19a. Bearing in mind that family-run companies, being locally based, are a cornerstone of regional development and territorial cohesion, urges the EU and the Member States to promote businesses of this type and encourage women to become more actively involved in family firms;

The Commission ishall be empowered to adopt a delegated act in accordance with Article 23 to supplement this directive. This act shall also provide for additional allocation from the new entrants reserve for significant production increases by applying the same thresholds and allocation adjustments as apply in respect of partial cessations of operation. activity variation levels. The threshold shall not exceed 10,000 allowances per year or 5% of the yearly allocation.

'In defining the principles for setting ex- ante benchmarks in individual sectors or subsectors, t(ac) In paragraph 2, subparagraph 1 is replaced by the following: 'The starting point shall be the average performance of the 10% most efficient installations in a sector or subsector in the CommunityUnion in the years 20017-20018. The Commission shall consult the relevant stakeholders, including the sectors and subsectors concerned.'

in the period between 2007-8 and each later period for which free allocations are determined in accordance with Article 11(1). This adjustment shall reduce the benchmark values set by the act adopted pursuant to Article 10a by 1% of the value that was set based on 2007-8 daprofits and reflect technological progress, takin respect of each year between 2008 and the middle of the relevant period of free allocation, unlessg into consideration the following:

(ba) paragraph 4 is replaced by the following: '4. Free allocation shall be given to district heating as well as to high efficiency cogeneration, as defined by Directive 2004/8/EC, for economically justifiable demand, in respect of the production of heating or cooling. In each year subsequent to 2013, the total allocation to such installations in respect of the production of that heat shall be adjusted by the linear factor referred to in Article 9.'

Allowances from the maximum amount referred to Article 10a(5) of this Directive which were not allocated for free up to 2020 shall be set aside for new entrants and, for significant production increases, together with 250 million and for adjustments to the maximum level of free allocation set in paragraph 5. In addition, the allowances placed in the market stability reserve pursuant to Article 1(3) of Decision (EU) 2015/… of the European Parliament and of the Council(*)1814 shall be set aside for this purpose.

1. Sectors and sub-sectors where the product exceeds 0.2 from multiplying their intensity of trade with third countries, defined as the ratio between the total value of exports to third countries plus the value of imports from third countries and the total market size for the European Economic Area (annual turnover plus total imports from third countries), by their district heating systems, shall be deemed to be at risk of carbon leakage. Such sectors and sub-sectors shall be allocated allowances free of charge for the period up to 2030 at 100% of the quantity determined in accordance with the measures adopted pursuant to Article 10a.

1. By derogation from Article 10a(1) to (5), Member States which had in 2013 a GDP per capita in €EUR at market prices below 60% of the Union average may give a transitional free allocation to installations forelectricity generation (including co-generation of heat and electricity production) for the modernisation of the energy sector.

1a. Member States shall be allowed to choose the most preferable free allowances allocation method in line with the following options and investments shall be selected on the basis of: (a) a competitive bidding process, (b) the National Investment Plans allocation which shall be based on criteria and rules referred to in paragraph 2a (new), or (c) a combination of both methods mentioned in point (a) and (b). Any Member State that is allowed to allocate allowances on the basis of this Article shall, by 31 December 2017, submit to the Commission an application containing the proposed allocation methodology.

2. The Member State concerned shall organise a competitive bidding process for projects with a total amount of investment exceeding €10 million to select the investments to be financed with free allocation. This competitive bidding processcompetitive bidding process referred to in point (a) of paragraph 1a shall:

(b) ensure that are eligible to bid only projects which contribute to the diversification of their energy mix and sources of supply,: - the necessary restructuring, environmental upgrading and retrofitting of the infrastructure, - clean technologies and, - use of cogeneration and/or - modernisation of the energy production, transmission and distribution sectors are eligible to bid(including district heating systems);

Where investments with a value of less than €10 million are supported with free allocation, the Member State shall select projects based on objective and transparent criteria. The results of this selection process shall be published for public comment. On this basis, the Member State concerned shall establish and submit a list of investments to the Commission by 30 June 2019.deleted

The eligible Member States intending to make use of optional free allocation via the National Investment Plans (NIPs) referred to in point (b) of paragraph 1a shall select investments fulfilling the following criteria: - the diversification of their energy mix and sources of supply, - the necessary restructuring, environmental upgrading and retrofitting of the infrastructure, - investment in clean technologies, - use of cogeneration and/or - modernisation of the energy production, transmission and distribution sectors (including district heating systems) While selecting investments for the purpose of NIPs, Member States shall take into account technological neutrality and ensure net positive gain in terms of emissions reduction. Only investments that have obtained all relevant corporate decisions after 24 October 2014 may be counted for this purpose. The method of this selection process and the final results shall be published for public consultation. On this basis, the Member State concerned shall establish and submit a list of investments months from the receipt of the list of investments, the Commission may request additional information concerning individual projects. The lack of decision by the Commission within the abovementioned period date means approval of the list of investments as submitted. The list of investments selected under the method referred to in this paragraph may be updated in 2023 and 2027, and submitted to the Commission. This paragraph shall be applied in case of any update.

4. Transitional fFree allocations shall be deducted from the quantity of allowances that the Member State would otherwise auction. The total free allocation shall be no more than 40% of the allowances which the Member State concerned receives in the period 2021-30 pursuant to Article 10(2)(a) spread out in equal annual volumes over the period from 2021-30. Free allocation that is not covered by the necessary expenditure in any given year shall be carried over and claimed during following years of the period between 2021 and 2030 when appropriate expenditure is incurred. Other ways of distributing the total number of allowances dedicated for the free allocation over the period between 2021 and 2030 shall be allowed provided that they are duly justified.

6. Member States shall require benefiting electricity generators and network operators to report by 28 February of each year on the implementation of their selected investments. Member States shall report on this to the Commissionannually by 31 March to the Commission on the balance of free allocation and investment expenditure incurred, and the Commission shall make such reports public.

2. The fund shall also finance small- scale investment projects in the modernisation of energy systems (including thermal energy, district heating, high efficiency cogeneration, renewable energy, geothermal heat) and energy efficiency. To this end, the investment boardeligible Member States shall develop guidelines and investment selection criteria specific to such projectsto in paragraph 4.

The fund shall be governed by an investment board and a management commitindividual allocations of each beneficiary Member State from the Modernisation Fund shall be governed by the eligible beneficiary Member Statee, which shall beassisted by the advisory board composed of representatives ofrom the beneficiary Member States, the Commission, and the EIB and three representatives elected by the other Member States for a period of 5 years. The investment board shall be responsible to determine a Union-level investment policy, appropriate financing instruments and investment selection criteria. The management committee shall be responsible for the day-to-day management of the fund.. Individual decisions on financing particular projects shall be taken by the eligible beneficiary Member State. Day-to- day management of the fund shall be executed by the beneficiary Member States. The advisory board shall be responsible for preparing the framework guidance on investment, including a Union-level investment policy, appropriate financing

The investmentadvisory board shall elect a representative from the Commission as chairman. The investment board shall chairman, the investment board shall take a decision by simple majoritybe chaired annually by one of the beneficiary Member States.

If the EIB recommends not financing an investment and provides reasons for this recommendation, a decision shall only be adopted if a majority of two-thirds of all members vote in favour. The Member State in which the investment will take place and the EIB shall not be entitled to cast a vote in this case. For small projects funded through loans provided by a national promotional bank or through grants contributing to the implementation of a national programme serving specific objectives in line with the objectives of the Modernisation Fund, provided that not more than 10% of the Member States' share set out in Annex IIb is used under the programme, the two preceding sentences shall not apply.deleted

6. Each year, the management committeeadvisory board shall report to the Commission and the European Parliament on experience with the evaluation and selection of investments. The Commission shall review the basis on which projects are selected by 31 December 2024 and, where appropriate, make proposals to the management committeeadvisory board.

A list of installations covered by this Directive for the fivetwo years beginning on 1 January 2021 shall be submitted by 30 September 2018, and lists for the subsequent fivetwo years shall be submitted every fivetwo years thereafter. Each list shall include information on production activity, transfers of heat and gases, electricity production and emissions at sub- installation level over the fivetwo calendar years preceding its submission. Free allocations shall only be given to installations where such information is provided.

1. Sectors and sub-sectors where the product exceeds 0.2 from multiplying their intensity of trade with third countries, defined as the ratio between the total value of exports to third countries plus the value of imports from third countries and the total market size for the European Economic Area (annual turnover plus total imports from third countries), by their district heating systems, shall be deemed to be at risk of carbon leakage. Such sectors and sub-sectors shall be allocated allowances free of charge for the period up to 2030 at 100% of the quantity determined in accordance with the measures adopted pursuant to Article 10a.

1. By derogation from Article 10a(1) to (5), Member States which had in 2013 a GDP per capita in €EUR at market prices below 60% of the Union average may give a transitional free allocation to installations forelectricity generation (including co-generation of heat and electricity production) for the modernisation of the energy sector.

1a. Member States shall be allowed to choose the most preferable free allowances allocation method in line with the following options and investments shall be selected on the basis of: (a) a competitive bidding process, (b) the National Investment Plans allocation which shall be based on criteria and rules referred to in paragraph 2a (new), or (c) a combination of both methods mentioned in point (a) and (b). Any Member State that is allowed to allocate allowances on the basis of this Article shall, by 31 December 2017, submit to the Commission an application containing the proposed allocation methodology.

2. The Member State concerned shall organise a competitive bidding process for projects with a total amount of investment exceeding €10 million to select the investments to be financed with free allocation. This competitive bidding processcompetitive bidding process referred to in point (a) of paragraph 1a shall:

(b) ensure that are eligible to bid only projects which contribute to the diversification of their energy mix and sources of supply,: - the necessary restructuring, environmental upgrading and retrofitting of the infrastructure, - clean technologies and, - use of cogeneration and/or - modernisation of the energy production, transmission and distribution sectors are eligible to bid(including district heating systems);

Where investments with a value of less than €10 million are supported with free allocation, the Member State shall select projects based on objective and transparent criteria. The results of this selection process shall be published for public comment. On this basis, the Member State concerned shall establish and submit a list of investments to the Commission by 30 June 2019.deleted

The eligible Member States intending to make use of optional free allocation via the National Investment Plans (NIPs) referred to in point (b) of paragraph 1a shall select investments fulfilling the following criteria: - the diversification of their energy mix and sources of supply, - the necessary restructuring, environmental upgrading and retrofitting of the infrastructure, - investment in clean technologies, - use of cogeneration and/or - modernisation of the energy production, transmission and distribution sectors (including district heating systems) While selecting investments for the purpose of NIPs, Member States shall take into account technological neutrality and ensure net positive gain in terms of emissions reduction. Only investments that have obtained all relevant corporate decisions after 24 October 2014 may be counted for this purpose. The method of this selection process and the final results shall be published for public consultation. On this basis, the Member State concerned shall establish and submit a list of investments months from the receipt of the list of investments, the Commission may request additional information concerning individual projects. The lack of decision by the Commission within the abovementioned period date means approval of the list of investments as submitted. The list of investments selected under the method referred to in this paragraph may be updated in 2023 and 2027, and submitted to the Commission. This paragraph shall be applied in case of any update.

4. Transitional fFree allocations shall be deducted from the quantity of allowances that the Member State would otherwise auction. The total free allocation shall be no more than 40% of the allowances which the Member State concerned receives in the period 2021-30 pursuant to Article 10(2)(a) spread out in equal annual volumes over the period from 2021-30. Free allocation that is not covered by the necessary expenditure in any given year shall be carried over and claimed during following years of the period between 2021 and 2030 when appropriate expenditure is incurred. Other ways of distributing the total number of allowances dedicated for the free allocation over the period between 2021 and 2030 shall be allowed provided that they are duly justified.

6. Member States shall require benefiting electricity generators and network operators to report by 28 February of each year on the implementation of their selected investments. Member States shall report on this to the Commissionannually by 31 March to the Commission on the balance of free allocation and investment expenditure incurred, and the Commission shall make such reports public.

2. The fund shall also finance small- scale investment projects in the modernisation of energy systems (including thermal energy, district heating, high efficiency cogeneration, renewable energy, geothermal heat) and energy efficiency. To this end, the investment boardeligible Member States shall develop guidelines and investment selection criteria specific to such projectsto in paragraph 4.

The fund shall be governed by an investment board and a management commitindividual allocations of each beneficiary Member State from the Modernisation Fund shall be governed by the eligible beneficiary Member Statee, which shall beassisted by the advisory board composed of representatives ofrom the beneficiary Member States, the Commission, and the EIB and three representatives elected by the other Member States for a period of 5 years. The investment board shall be responsible to determine a Union-level investment policy, appropriate financing instruments and investment selection criteria. The management committee shall be responsible for the day-to-day management of the fund.. Individual decisions on financing particular projects shall be taken by the eligible beneficiary Member State. Day-to- day management of the fund shall be executed by the beneficiary Member States. The advisory board shall be responsible for preparing the framework guidance on investment, including a Union-level investment policy, appropriate financing

The investmentadvisory board shall elect a representative from the Commission as chairman. The investment board shall chairman, the investment board shall take a decision by simple majoritybe chaired annually by one of the beneficiary Member States.

If the EIB recommends not financing an investment and provides reasons for this recommendation, a decision shall only be adopted if a majority of two-thirds of all members vote in favour. The Member State in which the investment will take place and the EIB shall not be entitled to cast a vote in this case. For small projects funded through loans provided by a national promotional bank or through grants contributing to the implementation of a national programme serving specific objectives in line with the objectives of the Modernisation Fund, provided that not more than 10% of the Member States' share set out in Annex IIb is used under the programme, the two preceding sentences shall not apply.deleted

6. Each year, the management committeeadvisory board shall report to the Commission and the European Parliament on experience with the evaluation and selection of investments. The Commission shall review the basis on which projects are selected by 31 December 2024 and, where appropriate, make proposals to the management committeeadvisory board.

– having regard to the 1989 UN Convention on the Rights of the Child, and the Optional Protocol to the Convention on the Rights of the Child on the sale of children, child prostitution and child pornography;

– having regard to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells;

B. whereas THB takes many different forms across many legal and illegal activities, including, but not limited to, agriculture, food processing, prostitution, domestic work, manufacturing, care, cleaning, other types of forced labour (particularly in the service industries), forced begging, forced marriage, illegal adoptions, gestational surrogacy and the trade in human organs, cells and tissues, including trade in reproductive cells as well as foetal cells and tissues;

23b. Recalls that the human body should not be a source of financial gain; calls on the Commission to condemn all sorts of THB with the purpose of the removal of organs and adopt a clear attitude toward illegal trade of organs, tissues and cells, including trade in reproductive cells and foetal tissues and cells;

32. Calls on the Member States to ensure gender-specific provision of services to victims of THB that is appropriate to their needs, recognising the form of trafficking to which they have been subjected; highlights that whilst a majority of victims are women and girls, there should be specialised services for victims of all genderswomen and men victims of THB;

67f. Condemns the practice of surrogacy that undermines human dignity of the woman as her body and its reproductive functions are used as a commodity, the practice of gestational surrogacy which involves reproductive exploitation and use of human body for financial or other gain, in particular of vulnerable women in developing countries, shall be prohibited and treated as a matter of urgency in human rights instruments;

67f. Condemns the practice of surrogacy that undermines human dignity of the woman as her body and its reproductive functions are used as a commodity, the practice of gestational surrogacy which involves reproductive exploitation and use of human body for financial or other gain, in particular of vulnerable women in developing countries, shall be prohibited and treated as a matter of urgency in human rights instruments;

67g. Calls for clear principles and international legal instruments addressing human rights issues related to surrogacy aiming at the prevention of human rights abuses, such as exploitation of women and human trafficking, and protection of rights, interests and wellbeing of children;

67g. Calls for clear principles and international legal instruments addressing human rights issues related to surrogacy aiming at the prevention of human rights abuses, such as exploitation of women and human trafficking, and protection of rights, interests and wellbeing of children;

72d. Calls for the establishment of efficient legal and policy framework strengthening the protection of rights of children before birth, especially in order to prevent sex-selective abortions, forced abortions as a part of family planning policies and similar practices incompatible with the right to life and human dignity;

72d. Calls for the establishment of efficient legal and policy framework strengthening the protection of rights of children before birth, especially in order to prevent sex-selective abortions, forced abortions as a part of family planning policies and similar practices incompatible with the right to life and human dignity;

For the calculation of a Member State’s gross final consumption of energy from renewable energy sources, the contribution from biofuels and bioliquids, as well as from biomass fuels consumed in transport, if produced from food or feed crops, shall be no more than 7% of final consumption of energy in road and rail transport in that Member State. This limit shall be reduced to 3,8% in 2030 following the trajectory set out in part A of Annex X. Member States may set a lower limit and may distinguish between different types of biofuels, bioliquids and biomass fuels produced from food and feed crops, for instance by setting a lower limit for the Member States may set a lower limit for the contribution from biofuels produced from oil crops, taking into accountribution from food or feed crop based biofuels produced from oil crops, taking indirect land use change.

(ba) For promoting the gross final consumption of energy from renewable sources in transport, Member States may set higher national mandates in the transport sector by authorising the use of sustainable biofuels, biomass fuels and renewable liquid and gaseous transport fuel of non-biological origin consumed in the transport sectors produced from

1. With effect from 1 January 2021, Member States shall requirset the fuel suppliers to include a minimum share of energy from advanced biofuelsincorporation obligation and shall increase gradually the share of renewable energy from conventional biofuels, as well as advanced and other biofuels and biogas produced from feedstock listed in Annex IX, from renewable liquid and gaseous transport fuels of non-biological origin, from waste-based fossil fuels and from renewable electricity in the total amount of transport fuels they supply for consumption or use on the market in the course of a calendar year.

(b) for the calculation of the numerator, the energy content of advanced biofuels and other biofuels and biogas produced from feedstock listed in Annex IXny types of biofuels and biogas, renewable liquid and gaseous transport fuels of non-biological origin, waste based fossil fuels supplied to all transport sectors, and renewable electricity supplied to road vehiclesand rail transport, shall be taken into account.

For the calculation of the numerator, the contribution from biofuels and biogas produced from feedstock included in part B of Annex IX shall be limited to 1.7% of the energy content of transport fuels supplied for consumption or use on the market and the contribution of fuels supplied in the aviation and maritime sector shall be considered to be 1.2 times their energy content.

(ba) For the calculation of the contribution from electricity produced from renewable sources and consumed in all types of electric vehicles and for the production of renewable liquid and gaseous transport fuels of non-biological from renewable energy sources in the Union or the share of electricity from renewable energy sources in their own country as measured two years before the year in question. Furthermore, for the calculation of the electricity from renewable energy sources consumed by electrified rail transport, that consumption shall be considered to be 2,5 times the energy content of the input of electricity from renewable energy sources. For the calculation of the electricity from renewable energy sources consumed by electric road vehicles in point (b), that consumption shall be considered to be five times the energy content of the input of electricity from renewable energy sources;

3. To determine the share of renewable electricity for the purposes of paragraph 1 either the average share of electricity from renewable energy sources in the Union or the share of electricity from renewable energy sources in the Member State where the electricity is supplied, as measured two years before the year in question may be used. However, electricity that is supplied to road vehicles and obtained from a direct connection to an installation generating renewable electricity or through power purchase agreements for renewable electricity from the grid, that electricity shall be fully counted as renewable electricity. In both cases, an equivalent amount of guarantees of origin issued in accordance with Article 19 shall be cancelled.

operation after or at the same time as the installation producing the renewable liquid and gaseous transport fuel of non- biological origin and (ii) is not connected to the grid, can be fully counted as renewable electricity for the production of that renewable liquid and gaseous transport fuel of non-biological origin. Similarly, electricity obtained through power purchase agreements for renewable electricity shall be fully counted as renewable electricity for the production of that renewable liquid and gaseous transport fuel of non-biological origin.

(b) When biomass isor biomass fuels are processed with fossil fuels in a common process, the amount of biofuel in the product shall be established applying adequate conversion factors to the biomass input. In case the process yields more than one product, all products stemming from the process shall be assumed to contain the same share of biofuel. The same rules shall apply for the purposes of Article 27(1).

7. By 31 December 2025, in the context of the biennial assessment of progress made pursuant to Regulation [Governance], the Commission shall assess whether the obligation laid down in paragraph 1 effectively stimulates innovation and promotes greenhouse gas savings in the transport sector, and whether the applicable greenhouse gas savings requirements for biofuels and biogas are appropriate. The Commission shall, if appropriate, present a proposal to modify the obligation laid down in paragraph 1. Any modification should at least maintain levels reflecting advanced biofuels installed and under construction capacity in 2025.

Ea. whereas the pharmaceutical sector takes advantage of various innovation incentives such as supplementary protection certificate, data exclusivity or market exclusivity which aim at promoting valuable innovation fulfilling unmet medical needs, and whereas these incentives do not always prove to attain those objectives.

G. whereas, due to the current international reference pricing system, the prices of medicines are usually negotiated by means of bilateral and confidential negotiations between the pharmaceutical industry and Member States;

23. Calls on the Commission to take a very cautious approach and guarantee safety and efficacy in any fast-track approval process and to introduce the concept of conditional authorisation based on effectivenesstakeholders;

- having regard to the European Court of Auditors report "Combating Food Waste: an opportunity for the EU to improve the resource-efficiency of the food supply chain" (2016)1a , _________________ 1a http://www.eca.europa.eu/en/Pages/DocIt em.aspx?did=40302.

Ba. whereas according to the World Food Programme (WFP) 795 million people in the world do not have enough food to lead a healthy and active life; whereas poor nutrition causes nearly half (45%) or approximately 3.1 million of deaths in children under the age of five; whereas one in six children in the world are underweight and one in four is stunted; whereas it is therefore not only an economic and environmental but also a moral obligation to reduce food waste1a ; _________________ 1a https://www.wfp.org/hunger/stats.

1. Stresses the urgent need to reduce the amount of food waste in the Union at every step of the supply and consumption chain; in this regard, underlines the importance of political leadership and commitment from both the Commission and Member States; reminds that the European Parliament repeatedly, in its resolutions from 2011, 2012, 2015 and 2016, asked the Commission to take action against food waste;

7. Welcomes the recent creation of the EU Platform on Food Losses and Food Waste; reiterates the importance of exchanging best practices, combining knowledge and avoiding duplication with other relevant forums such as for example the EU Retail Forum on Sustainability, the European Food Sustainable Consumption and Production Roundtable, the High Level Forum for a Better Functioning Food Supply Chain, the Consumer Goods Forum;

8. Encourages the Commission and the Member States to engage, in cooperation with stakeholders, in improving consumers’ understanding of ‘use by’ dates and ‘best before’ dates; stresses the importance of empowering consumers in order to make informed decisions; asks the Commission to assess whether current EU legislation and current practice in use with ‘use by’ and ‘best before’ dates in different Member States are fit for purpose;

10. Calls on the Commission and the used by stakeholders; encourages the Member States to reduce food waste in public establishments; in this regard emphasizes the importance of educating and engaging children to minimize food waste in school canteens; asks the Quaestors to give priority to actions to reduce food waste in the European Parliament and encourages other European institutions to follow;

1. Welcomes the implementation of the political agreement leading to early parliamentary elections on 11 December 2016 and the respect for fundamental freedoms shown at the elections of 11 December 2016; urges all political parties to accept its results in the interest of domestic stability and underlines their responsibility to ensure that there is no backsliding into political crisis; calls for a swift formation of a new government in order to make use of the mandate to carry on with necessary reforms; considers cross- party cooperation essential for addressing pressing domestic and EU-related challenges;

4. Underlines the strategic importance of supporting further progress in the process of EU integration and urges once again that the political will be shown to fully implement the Urgent Reform Priorities and the Przhino Agreement; calls on the Commission to assess, at its earliest convenience but before the end of 2017, the country’s progress on implementation and to report back to Parliament; while recalling that long overdue reforms need to be launched and implemented, supports the continuation of the High Level Accession Dialogue (HLAD) for systematically assisting the country in this endeavour; draws attention to the potential negative consequences of further delays in the country’s accession process;

4 b. Underlines the significant progress country has made in the process of EU integration and emphasizes the negative consequences of further delaying the process of integration, including the threat to the credibility of the EU enlargement policy and the risk of instability in the region;

4 d. Welcomes the high level of legislative alignment with the acquis communautaire and acknowledges the priority given to the effective implementation and enforcement of existing legal and policy frameworks, as in the case of countries already engaged in the accession negotiations;

6. Notes some progress, although limited, in reforming public administration including the steps to implement the new legal framework on human resources management; remains concerned abouthat the politicisation ofcountry's public administration remains fragmented and politicised and that civil servants are subject to political pressure and intimidation; urges the new government to enhance professionalism, neutrality and independence at all levelsdemonstrate a strong political commitment in order to enhance professionalism, transparency, accountability, meritocracy, equal representation, neutrality and independence at all levels; calls in this context for the suspension and review of the implementation of the law on transformation of temporary positions into permanent contracts until the principle of merit is fully observed; stresses the need to complete the 2017-2022 public administration reform strategy, including by making sufficient budget allocations for its implementation, and to strengthen relevant administrative capacity;

13. Welcomes the adoption of the national strategy for equality and non- discrimination 2016-2020; is concerned about impartiality and the independence of the Commission for Protection from Discrimination; reiterates its condemnation of hate speech against discriminated groups; is concerned that intolerance against lesbian, gay, bisexual, transgender and intersex (LGBTI) people persists; reiterates its call for the Anti- Discrimination Law to be aligned with the education system and the labour market; is concerned about the inhumane physical conditions in prisons, despite a significant increase in the prison budget;

14. Is concerned about the lack of implementation of the Law on Equal Opportunities and the limited effectiveness of institutional mechanisms to advance gender equality between men and women; urges the competent authorities to make sufficient budget allocations for its implementation and to improve support services to victims of domestic violence;

21 a. Emphasizes the importance of regional cooperation as a tool to drive the process of EU integration forward and commends country's constructive efforts and proactive contributions in promoting bilateral relations with all countries from the region;

22. Welcomes Macedonia’s continued constructive role in regional and international cooperation; commends the increased alignment with EU foreign policy (73 %); reiterates the importance of finalising the negotiations on a bilateralcommends also the positive focus on bilateral projects in areas of finalization of the talks on the Treaty of Friendship, Good-Neighbourliness and Cooperation; emphasizes the necessity to respect the history, sovereignty and national and linguistic identity of both Macedonia and Bulgaria;

23 a. Welcomes the efforts of the Berlin Process, which demonstrated strong political support for the European perspective of the Western Balkans and that will continue to encourage further reforms in key areas and promote economic developments through core connectivity investments, providing concrete results for the citizens and the entire region; welcomes the establishment of the RYCO (Regional Youth Cooperation Office) and the Western Balkans Fund and requests the EU to take into account the initiatives and projects which have been proposed by Macedonia;

23 b. Commends the country on its chairmanship of the CEI, focusing on economic cooperation and business opportunities, infrastructure and general economic development, including rural development and tourism, as well as on bridging macro-regions throughout 2015;

2. Welcomes the progress on the implementation of the 2015-2018 Reform Agenda, as well as the country’snd calls for determination toin pursueing further institutional and socio-economic reforms, including the necessary reform of electoral law, that will ensure progress on BiH's path to EU membership as well as ensure equal rights of all three constituent peoples; stresses that harmoniszed implementation of the Reform Agenda is needed to achieve real change across the country and to improve the lives of all BiH citizens; calls for the reform momentum to be maintained in order to transform BiH into a fully effective, inclusive and functional state; regrets that common reform efforts often continue to be hampered by ethnic and political divisions; considers it essential toto advance in a concerted manner on the rule of law, including the fight against corruption and organised crime, the reform of the judiciary and public administration;

9. Reiterates its concern about the 9.prosecution of war crimes, as well as strengthening judicial independence and fighting corruption in the judiciary; urges the rapid adoption of the action plan for the implementation of the 2014-2018 justice sector reform; welcomes the adoption of the law on free legal aid at state level and the introduction by the High Judicial and Prosecutorial Council of guidelines on prevention of conflict of interest, the drafting of integrity plans and disciplinary measures; notes the important role of the Structured Dialogue on Justice in addressing the shortcomings in the BiH judiciary;

16. Underlines the need for a substantial improvement in the strategic, legal, institutional and policy frameworks on the observance of human rights; calls for the adoption of a countrywide strategy comprehensive and integrated approach to the social inclusion of Roma; welcomes the fact that some governments and parliaments have begun discussing LGBTI rights and drawing up specific measures for their protection; welcomes changes to the BiH anti-discrimination law extending the listed grounds for discrimination to age, disability, sexual orientation and gender identity;

18. Deplores the fact that BiH is still in breach of the European Convention on Human Rights for not implementing the rulings of the European Court of Human Rights (ECHR) in the Sejdić-Finci, Zornić and Pilav cases; strongly calls for progress to be made in this regard in order to advance the country’'s EU perspective and establish a functional democratic society in which equal rights of all constituent peoples and citizens of BiH is guaranteed;

20. Remains concerned by the continued fragmentation, inefficiency and complexity of the education system; calls for countrywide common core curricula and better coordination between the different levels of education governance, in a way to still ensure the right of children to education in their own language; continues to be concerned about the persistently high school-drop-out rates of Roma pupils; regrets the slow progress in addressing and resolving the issue of ‘two schools under one roof’ and other forms of segregation and discrimination in schoolsarding the system' two schools under one roof' calls on the authorities to promote the principles of tolerance and dialogue as well as the right of all constituent peoples to education in their own language;

23 a. Notes that progress in the areas of transboundary air pollution and especially the pollution caused by the Bosanski Brod oil refinery, whose harmful impact is cutting across borders and affecting the quality of life and the health of people living in Slavonski Brod; maintains that BiH needs to comply in full with its obligations under the Convention on Environmental Impact Assessment in a Transboundary Context (Espoo, 1991) and the Protocol on Strategic Environmental Assessment (Kiev, 2003), not least as regards activities in the Neretva and Trebišnjica river basin;

(1) In accordance with Article 2 of the (1) Treaty of the European Union, ‘the Union human rights, including the rights of the persons belonging to minorities. In particular and in accordance with the Universal Declaration of Human Rights, human dignity is the primary foundation of all fundamental human rights. These values are common to the Member States in a society where pluralism, non- discrimination, tolerance, justice, solidarity and equality between women and men prevail’. Article 3 further specifies that the ‘Union’s aim is to promote peace, its values and the well-being of its people’ and, among others, ‘it shall respect its rich cultural and linguistic diversity, and shall ensure that Europe’s cultural heritage is safeguarded and enhanced’. Those values are further reaffirmed and articulated in the rights, freedoms and principles enshrined in the Charter of Fundamental Rights of the European Union.

(2) Those fundamental human rights and values must (2) continue to be promoted and enforced and shared among the citizens and peoples and be at the heart of the EU project, on the basis of the idea that fundamental human rights are universal, indivisible, interdependent and interrelated. Therefore, a new Justice, Rights and Values Fund, comprising the Rights and Values and the Justice programmes shall be created in the EU budget. At a time where European societies are confronted with extremism, radicalism and divisions, it is more important than ever to promote, strengthen and defend justice, rights and EU values: human rights, respectvalues: human rights, respect for human dignity, freedom, democracy, equality, the rule of law. This will have profound and direct implications for political, social, cultural and economic life in the EU. As part of the new Fund, the Justice Programme will continue to support the further development of Union area of justice and cross-border cooperation. The Rights and Values Programme will bring together the 2014-2020 Programme Rights, Equality and Citizenship established by Regulation (EU) No 1381/2013 of the European Parliament and of the Council8 and the Europe for Citizens programme established by Council Regulation (EU) No 390/20149, (hereafter ‘the predecessor Programmes’). __________________ 8 Regulation (EU) No 1381/2013 of the European Parliament and of the Council of 17 December 2013 establishing a Rights, Equality and Citizenship Programme for the period 2014 to 2020 (OJ L 354, 28.12.2013, p. 62) 9 Council Regulation (EU) No 390/2014 of 14 April 2014 establishing the ‘Europe for Citizens’ programme for the period 2014- 2020 (OJ L 115, 17.4.2014, p.3)

(3) The Justice, Rights and Values Fund and its two underlying funding programmes will focus primarily on people and entities, which contribute to make our common values, fundamental human rights and rich diversity alive and vibrant. The ultimate objective is to nurture and sustain rights-based, equal, inclusive and democratic society. That includes a vibrant civil society, encouraging people’s democratic, civic and social participation and fostering the rich diversity of European society, based on our common history and memory. Article 11 of the Treaty of the European Union further specifies that the institutions shall, by appropriate means, give citizens and representative associations the opportunity to make known and publicly exchange their views in all areas of Union action. Article 17 of the Treaty on the Functioning of the European Union sets out that the Union shall maintain a dialogue with the churches and organisations mentioned in that Article. Churches and religious communities or associations are long- standing primary stakeholders in fostering protection and promotion of fundamental human rights and should be granted the same access as civil society organisations to the relevant funding opportunities.

(5) In order to bring the European Union closer to its citizens, a variety of actions and coordinated efforts are necessary. Bringing together citizens in town-twinning projects or networks of towns and supporting civil society organisations in the areas covered by the programme will contribute to increase citizens’ engagement in society and ultimately their involvement in the including intercultural and interreligious dialogue, and respect for others fosters a sense of belonging and a European identity, based on a shared understanding of European values, culture, history and heritage. Increasing plurality and global migration movements raise the importance of intercultural and inter- religious dialogue in our societies. Full support should be given to inter-religious dialogue as a part of social harmony in Europe and a key element in solving social tensions. Interreligious dialogue could also help to highlight the positive contribution of religion to social cohesion. As religious illiteracy sets the stage for the misuse of religious feelings among the population, support for projects and initiatives developing religious literacy is also important. The promotion of a greater sense of belonging to the Union and of Union values is particularly important amongst citizens of the EU outermost regions due to their remoteness and distance from continental Europe.

(6) Remembrance activities and critical reflection on Europe’s historical memory are necessary to make citizens, in particular young citizens, aware of the common history, as the foundation for a common future, moral purpose androoted in Europe’s spiritual and moral heritage and based on shared values. The relevance of historical, spiritual, cultural and, intercultural and interreligious aspects should also be taken into account, as well as the links between remembrance and the creation of a European identity and sense of belonging together.

(9) Gender-based violenceViolence against women and violence against children and young people constitute a serious violation of fundamental rights. Violence persists throughout the Union, in all social and economic contexts, and has serious repercussions on victims’ physical and psychological health and on society as a whole. Children, young people and women are particularly vulnerable to violence, in particular in close relationships. Action should be taken to promote the rights of the child and to contribute to the protection of children from harm and violence, which pose a danger to their physical and mental health and constitute a breach of their rights to development, protection and Combating all forms of violence, promoting prevention and protecting and supporting victims are priorities of the Union which help fulfil individuals’ fundamental rights and contribute to equality between women and men. Those priorities should be supported by the Programme.

(11) Non-discrimination is a fundamental principle of the Union. Article 19 of the Treaty on the Functioning of the European Union provides for action to combat discrimination based on sex, racial or ethnic origin, religion or belief, discrimination entails not only that similar situations should not be treated differently, but also that different situations should not be treated in the same way. The specific features of the diverse forms of discrimination should be taken into account and appropriate action should be developed in parallel to prevent and combat discrimination on one or more grounds. The Programme should support actions to prevent and combat discrimination, racism, xenophobia, anti- Semitism, anti-muslim hatred and other forms of intolerance. In that context, particular attention should also be devoted to preventing and combating all forms of violence, hatred, segregation and stigmatisation, including anti-religious stigmatisation, as well as combating bullying, harassment and intolerant treatment. The Programme should be implemented in a mutually reinforcing manner with other Union activities that have the same objectives, in particular with those referred to in the Commission Communication of 5 April 2011 entitled ‘An EU Framework for National Roma Integration Strategies up to 202010’ and in the Council Recommendation of 09 December 2013 on effective Roma integration measures in the Member States11. Authorities at Union and national level have an obligation to prevent discrimination on grounds of belonging to a religious group or carrying out religious acts, whether affiliated to majority or minority religious denominations. Furthermore, focus should not be placed on discrimination of religions, but on people being discriminated because of their religious affiliation or practices. An effective protection by the Member States of the right to conscientious objection, both at the individual and institutional level, especially in the healthcare, rule of law should also be supported. __________________ 10 COM(2011)173. 11 OJ C 378, 24.12.2013, p. 1.

(12) Attitudinal and environmental barriers as well as lack of accessibility hinder the full and effective participation of people with disabilities in society, on an equal basis with others. People with disabilities are faced with barriers to, among other things, access the labour market, benefit from an inclusive and quality education, avoid poverty and social Convention on the Rights of Persons with Disabilities (the UNCRPD), the Union and all its Member States have committed to promote, protect and ensure the full and equal enjoyment of all human rights and fundamental freedoms by all persons with disabilities. The provisions of the UNCRPD have become an integral part of the Union legal order. Specific needs in the area of disability should be fully taken into account in the relevant funding efforts.

B. whereas AI is key, in industry and services associated with high technology, to turning B. Europe into a ‘start-up continent’ by exploiting the latest technologies to generate growth in Europe, in particular in the areas of health technology, healthcare services and programmes, drug discovery, robotic and robot-assisted surgery, and medical imaging and records;

D. whereas there are strong ethical concerns about the autonomy of robots and their impact on the doctor-patient relationshipuse of word ´autonomous´ for complex AI systems since the autonomy as such can only be attributed to human beings;

-1a. Stresses that AI systems and robots are innovative technological means to improve people´s lives, grow the economy, and address challenges in health, environment, climate change, food safety among many others with human agent being always responsible for their use;

22 a. Reiterates its condemnation of the practice of surrogacy, which undermines the human dignity of the woman since her body and its reproductive functions are used as a commodity; emphasises that the practice of gestational surrogacy which involves reproductive exploitation and use of the human body for financial or other gain, in particular in the case of vulnerable women in developing countries, shall be prohibited and treated

23 b. Stresses that sale of children in the context of surrogacy shall be prosecuted with a focus primarily on intermediaries, and, should not, unless special circumstances, include surrogate mothers, who may often be regarded as exploited

23 c. Stresses that there is no “right to a child” under international law and therefore the State cannot guarantee or provide it as a good or service; considers that “right to a child” approach constitutes a fundamental denial of the equal human rights of the child and undermines the fundamental premise of children as persons with human rights;

23 d. Calls for establishment of efficient legal and policy framework strengthening the protection of rights of children before birth, especially in order to prevent sex- selective abortions, forced abortions as a part of family planning policies and similar practices incompatible with right to life and human dignity;

Charles University in Prague, Medical Faculty (1972-1978). Certificate of postgraduate study in anaesthesiology and reanimation (1982). Certificate of postgraduate study in general medicine (1984). Doctor at an anaesthesiological and resuscitation department (since 1978). General practitioner (since 1994). External teacher at the Institute of Medical Ethics and Bioethics (Bratislava) (1991-1992).

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Vice-Chairman of a District National Committee (Dolný Kubín) (1990-1991). Head of the Department for International Relations at the Ministry of Health of the Slovak Republic (1991-1992). Chairman of KDH (Christian Democratic Movement) (Orava region) (1992-1994). Member of the National Council of the Slovak Republic for KDH (1994-1998). Member of the National Council of the Slovak Republic for SDK (Slovak Democratic Coalition)/KDH (1998-1999). Member of the Committee on Social Affairs and Health Care (1994-1998). Member of the EU-Slovak Republic Joint Parliamentary Committee (1995-1998). Member of the Foreign Affairs Committee of the National Council of the Slovak Republic (1998-1999).

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Ambassador Extraordinary and Plenipotentiary of the Slovak Republic to Canada (1999-2002).

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President of the citizens' association 'Donum Vitae'.

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Delegation for relations with the countries of Central America

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start

2014-07-14

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Addresses/Postal/2

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Old

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2014-07-07

Addresses

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2014-07-01

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2014-06-30

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2014-03-18

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2014-01-23

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Brussels

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Európsky parlament

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2009-09-16

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ENVI

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DROI

Staff

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PE

2012-03-09

Committees

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Substitute

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2012-03-08

Committees

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DROI

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Member

abbr

Delegations/0

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Organization

Delegation for relations with the Korean Peninsula

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DKOR

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Organization

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Delegations/1

deleted

Organization

Delegation for relations with Belarus

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abbr

D-BY

Delegations/2

added

Organization

Delegation to the Euro-Latin American Parliamentary Assembly

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Organization

Delegation to the Euro-Latin American Parliamentary Assembly

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abbr

DLAT

2012-02-10

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Member

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Committees/0

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Organization

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committee_id

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2014-01-31

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Environment, Public Health and Food Safety

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DROI

committee_id

DROI

Committees/2

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2014-01-31

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start

2009-07-14

Constituencies/0

deleted

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2014-01-31

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Kresťanskodemokratické hnutie

Delegations/0

added

Organization

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Member

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DKOR

Delegations/0

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start

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role

Member

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2014-01-31

abbr

DKOR

Organization

Delegation for relations with the Korean Peninsula

Delegations/1

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D-BY

Delegations/1

deleted

start

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2014-01-31

abbr

D-BY

Organization

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Delegations/2

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abbr

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groupid

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Staff/0

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Member

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PE

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2014-01-31

abbr

PE

Organization

European Parliament

2012-01-21

Addresses

added

Brussels

Phone

+322 28 45289

Fax

+322 28 49289

Address

Building

Bât. Altiero Spinelli

City

Bruxelles/Brussel

Office

03F349

Zip

B-1047

building_code

ASP

Street

60, rue Wiertz / Wiertzstraat 60

Organization

Parlement européen

Postal

Európsky parlament

Rue Wiertz

Altiero Spinelli 03F349

B-1047 Brusel

Strasbourg

Phone

+333 88 1 75289

Fax

+333 88 1 79289

Address

Building

Bât. Louise Weiss

City

Strasbourg

Office

T09012

building_code

LOW

Street

1, avenue du Président Robert Schuman

Zip2

F-67070

Organization

Parlement européen

Zip1

CS 91024

Birth

added

date

1952-09-11

place

Dolný Kubín

CV

added

Charles University in Prague, Medical Faculty (1972-1978). Certificate of postgraduate study in anaesthesiology and reanimation (1982). Certificate of postgraduate study in general medicine (1984). Doctor at an anaesthesiological and resuscitation department (since 1978). General practitioner (since 1994). External teacher at the Institute of Medical Ethics and Bioethics (Bratislava) (1991-1992).

Vice-Chairman of a District National Committee (Dolný Kubín) (1990-1991). Head of the Department for International Relations at the Ministry of Health of the Slovak Republic (1991-1992). Chairman of KDH (Christian Democratic Movement) (Orava region) (1992-1994). Member of the National Council of the Slovak Republic for KDH (1994-1998). Member of the National Council of the Slovak Republic for SDK (Slovak Democratic Coalition)/KDH (1998-1999). Member of the Committee on Social Affairs and Health Care (1994-1998). Member of the EU-Slovak Republic Joint Parliamentary Committee (1995-1998). Member of the Foreign Affairs Committee of the National Council of the Slovak Republic (1998-1999).

Ambassador Extraordinary and Plenipotentiary of the Slovak Republic to Canada (1999-2002).